APPENDIX 2.2Detection of Bile Leak

Publication Details

INDICATION OVERVIEW

Perforation or blockage of the bile duct can occur after surgeries such as laparoscopic cholecystectomy or liver transplant, or could happen following trauma.1 A retrospective and prospective study2 of Canadian patients with biliary leaks post cholecystectomy reported the frequency of the symptoms that patients with leak experienced, as follows: abdominal pain (89%), fever (43%), abdominal tenderness (81%), jaundice (43%), nausea and vomiting (43%), and ascites or mass (2%).

Population: Adults and children with suspected bile leak.

Intervention: Cholescintigraphy (also known as hepatobiliary scintigraphy [HBS] or hepatobiliary iminodiacetic acid [HIDA] scan).

Nuclear imaging is used to visualize the perforations or blockages. The isotope attaches to liver cells (hepatocytes) and is excreted in bile.3 The imaging will detect bile in areas where it should not be, indicative of a leak, or will show a lack of bile in areas where it should be (such as the gall bladder), indicative of an obstruction.

The radioisotopes used for the cholescintigraphy are all iminodiacetic acid derivatives and include mebrofenin, disofenin, and diisopropyl.

Comparators: For this report, the following diagnostic tests are considered as alternatives to cholescintigraphy:

  • Computed Tomography (CT): In a CT scan, a rotating x-ray device moves around the patient and takes detailed multiple images of organs and body parts.4 Sometimes patients are injected with a contrast dye before images are taken, for better visualization of the body part being examined.4 CT findings consistent with bile leak include the presence of fluid collections in the gallbladder fossa.5
  • Endoscopic Retrograde Cholangiopancreatography (ERCP): An ERCP is a test using an endoscope and x-rays to examine a patient’s bile and pancreatic ducts.6 During the ERCP, an endoscope is placed in the patient’s mouth and passed through the esophagus, stomach, and intestine. The endoscope is a long, flexible tube that contains a lens and a light source that allows for viewing inside the body. Patients are given sedation and need to fast six to eight hours prior to the examination.7
  • Magnetic Resonance Cholangiopancreatography (MRCP): An MRCP is a magnetic resonance imaging (MRI) test that produces detailed images of the hepatobiliary and pancreatic systems. Images are created using a magnetic field and radiofrequency pulses. Patients undergoing MRI are placed onto a table that is moved into the centre of the MRI machine. Some patients are given contrast material before the MRI. MRCP findings indicative of bile leak include the presence of fluid near the perforation site and related bile duct anomalies.8
  • Ultrasound (U/S): During a U/S, a transducer is placed over the organ of interest. The transducer generates sound waves that pass through the body and produce echoes, which are analyzed by a computer to produce images of the body part being analyzed.9 In the detection of bile leak, U/S can detect fluid collections that could be indicative of bile leak in the abdomen and hepatic system.5,10

Outcomes: Eleven outcomes (referred to as criteria) are considered in this report:

  • Criterion 1: Size of the affected population
  • Criterion 2: Timeliness and urgency of test results in planning patient management
  • Criterion 3: Impact of not performing a diagnostic imaging test on mortality related to the underlying condition
  • Criterion 4: Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition
  • Criterion 5: Relative impact on health disparities
  • Criterion 6: Relative acceptability of the test to patients
  • Criterion 7: Relative diagnostic accuracy of the test
  • Criterion 8: Relative risks associated with the test
  • Criterion 9: Relative availability of personnel with expertise and experience required for the test
  • Criterion 10: Accessibility of alternative tests (equipment and wait times)
  • Criterion 11: Relative cost of the test.

Definitions of the criteria are in Appendix 1.

METHODS

The literature search was performed by an information specialist using a peer-reviewed search strategy.

Published literature was identified by searching the following bibliographic databases: MEDLINE with In-Process records via Ovid; The Cochrane Library (2011, Issue 1) via Wiley; PubMed; and University of York Centre for Reviews and Dissemination (CRD) databases. The search strategy consisted of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were radionuclide imaging and biliary leak.

Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses (HTA/SR/MA), randomized controlled trials, non-randomized studies, and diagnostic accuracy studies. No date or human limits were applied to the HTA/SR/MA search. For primary studies, no date limit was applied, but the search was limited to the human population. Both searches were also limited to English language documents. Regular alerts were established to update the search until October 2011. Detailed search strategies are located in Appendix 2.

Grey literature (literature that is not commercially published) was identified by searching relevant sections of the CADTH Grey Matters checklist. Google was used to search for additional web-based materials. The searches were supplemented by reviewing the bibliographies of key papers. See Appendix 2 for more information on the grey literature search strategy.

Targeted searches were done as required for the criteria, using the aforementioned databases and Internet search engines. When no literature was identified that addressed specific criteria, experts were consulted.

SEARCH RESULTS

Two potential clinical articles were identified through the MA/SR/HTA filtered search and neither was subjected to full text review. A total of 511 primary studies were identified with the primary studies search, of which 96 were subjected to full-text screening.

Fourteen articles were retained that provided information for the following criteria: affected population;2,11,12 urgency;13 morbidity and quality of life;1315 acceptability of the test to patients;16,17 diagnostic accuracy;5,10,1820 risks;16 and availability.16 The remaining 43 citations were articles found through searching the grey literature, articles from the targeted searches, or articles from the reference lists of the identified potential articles.

SUMMARY TABLE

Table 1. Summary of Criterion Evidence (PDF, 284K)

CRITERION 1: Size of affected population (link to definition)

Bile leaks may occur after liver transplantation, hepatectomy (liver resection), trauma, or cholecystectomy. The number of liver transplantations in Canada has been increasing over the last decade, with 409 transplants performed in 2000 and 452 performed in 2009. Of these transplants, 65% were done in males.21 The average (SD) annual liver resection rate in Ontario in 2001 was 5.90 (4.0) per 100,000 people.22

The overall annual rate (95% confidence interval [CI]) of elective cholecystectomy (gallbladder removal) in Ontario, from 1988 to 2000, was 134.6 (133.6 to 135.6) per 100,000 people for men and 367.5 (365.9 to 369.1) per 100,000 people for women.23

A systematic review44 included 55 articles reporting on biliary complications related to biliary reconstruction during liver transplantation. The authors give no details on the quality of these articles except to state that no articles published before 1990 were included. There were 11,397 cases and 936 were complicated with biliary leakage with a mean incidence of 8.2%. The mean incidence was lower for deceased-donor whole liver transplants (7.8%, 668/8,585) and higher for living-donor transplants (9.5% 268/2,812). Incidence of bile leak for liver donors is reported to be 2% to 5% from institutional data from Tucker and Heaton.45

In a study conducted by Vigano et al., post-operative leak occurred in 5.7% of patients (34/593) who had undergone a hepatectomy.46 Vigano et al. also reported that over the past decade, the incidence of bile leak ranged from 1.7% to 9.2%, and within a cohort of 610 consecutive hepatic resections, the incidence of bile leak was 3.6%.46 A retrospective study of 616 patients undergoing hepatectomy from January 1989–1998 had an incidence of bile leak of 5.5%.12 In cases of liver resection, bile leaks occur at a rate ranging from 3.6% to 17%.47

The prognosis after a bile leak varies according to the site of the leak and the etiology.24 Leaks are more common with duct-enteric anastomosis than duct-duct anastomosis.24

A prospective study of 71 patients undergoing laparoscopic cholecystectomy reported an incidence of 11.3% of bile leaks.11 Sixty-four patients evaluated over a five-year period in a study conducted by Barkun et al. reported an incidence rate of 1.1% in patients post laparoscopic cholecystectomy.2

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CRITERION 2: Timeliness and urgency of test results in planning patient management (link to definition)

The priority for cholescintigraphy in diagnosing suspected post-operative biliary leak is stat to 24 hours after symptom onset, according to the Saskatchewan Ministry of Health (Patrick Au, Acute and Emergency Services Branch, Saskatchewan Ministry of Health: unpublished data, 2011). Delays in diagnosis and therapy frequently result in sepsis and death.24

Surgical repair for an ongoing bile leak may compromise the patient, as the bile may be toxic and contribute to additional infection that could lead to poor surgical healing; therefore, some argue that early detection is best treated with drainage.13

A study evaluating spontaneous healing of bile leaks examined the correlation between the delay of bile leakage post-operation and interventional treatment. Of 34 patients, leaks in 26 patients healed spontaneously (76.5%), and the conservative treatment failed in eight patients (23.5%). The authors concluded that a “wait and see” approach, compared with interventional treatment (after diagnosis), is successful in most cases.46 Delayed repair of injured biliary tracts is recommended instead of immediate repair.45

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CRITERION 3: Impact of not performing a diagnostic imaging test on mortality related to the underlying condition (link to definition)

It has been reported that 44% of patients with bile duct leaks may develop a serious post-operative complication, which could include peritonitis, sepsis, abscess, pulmonary infiltrates, and death.48 A 30-day mortality rate of 2.6% has been reported, as well as a 7.8% in-hospital mortality rate.48 Sepsis, leading to multisystem organ failure, is the most common cause of death.48

Similar mortality rates were reported by Vigano et al.46 from a study of patients with post-operative bile leakage. Two of 34 patients (5.9%) with post-operative bile leakage died. One patient died of sepsis with persistent bile leakage 46 days after onset, and the second patient experienced tumour progression with persistent bile leakage and died five months after onset.

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CRITERION 4: Impact of not performing a diagnostic imaging test on morbidity or quality of life related to the underlying condition (link to definition)

In a series of case reports presented by Tucker et al., morbidity associated with bile leak included jaundice, abdominal pain, leukocytosis, fever, and shoulder pain.45

The presence of bile and blood in the peritoneal cavity due to leakage may impair the host immune system and allow for the development of sepsis, liver failure, and mortality.12 Bile leak from the parenchymal cut surface can lead to the development of biloma and intra-abdominal infection with abscess.45

Vigano et al.46 evaluated a post-operative bile leakage population of 34 patients with a mean age of 62 years. Although 76.5% patients experienced spontaneous healing after 15 days of the procedure, eight patients did not. Five patients (14.7%) developed associated morbidity accompanying leakage and three patients developed significant morbidity (8.82%), which included sepsis in two and bile peritonitis in one.46

Persistent bile leak or drainage can lead to invasive treatment such as ERCP, sphincterotomy, and stent placement. These procedures assist in defining the location of the leak and assist with enteric biliary damage and leak closure. Nasobiliary tubes may also be used to decompress the bile duct and resolve the bile leak.45,47 Although leaks do heal over time with such interventions, they may persist for months.47 In some cases, surgical repair or biliary reconstruction, including revising the Roux-en-Y hepaticojejunostomy, creating a new hepaticojejunostomy, or reinforcing the anastomosis with polydioxanone suture (PDS).13

One study14 that followed 40 patients hospitalized after trauma reported statistically significantly (P < 0.0001) longer hospital stays for patients who experienced bile leaks compared with those who did not have bile leaks. The mean (SD) length of hospital stay was 53 days (24 days; range 26 to 70 days) for bile leaks compared with a mean of 14 days (12 days; range three days to 61 days) for patients with no bile leaks.

Pediatric

Bile leak can manifest clinically after a latent period15 following blunt trauma in children. A delay in the diagnosis of bile duct injury may result in increased morbidity and prolonged hospitalization.

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CRITERION 5: Relative impact on health disparities (link to definition)

To be scored locally.

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CRITERION 6: Relative acceptability of the test to patients (link to definition)

Cholescintigraphy

Patients may have concerns about radiation exposure and the intravenous injection of a radiopharmaceutical agent.

CT

Patients undergoing CT scan may have concerns about radiation exposure and may also feel claustrophobic while in the scanner. This is less of a problem with new CT scanners (MIIMAC expert opinion). Patients may be required to hold their breath for a substantial period of time, which is seen as “uncomfortable” and “difficult,” particularly for patients with severe abdominal pain.25

ERCP

ERCP is a relatively invasive test. It involves inserting an endoscope through the patient’s mouth, and down the esophagus until it reaches the duodenum. Patients with altered surgical anatomy may not be suitable for ERCP, especially in cases where a Roux-en-Y anastomosis is required due to unusual anatomical features post-surgery.16

MRCP

MRCP is an MRI-based imaging test. Because of the closed space of an MRI, patients may experience feelings of claustrophobia, as well as be bothered by the noise. This may be less of a problem with new MRI machines, if available (MIIMAC expert opinion). It has been reported that up to 30% of patients experience apprehension and 5% to 10% endure some severe psychological distress, panic, or claustrophobia.26,27 Some patients may have difficulty remaining still during the scan. Patients are not exposed to radiation during an MRI scan, which may be more acceptable to some.

Menon et al.28 compared patient satisfaction in 34 patients who underwent both ERCP and MRCP. Patients completed a questionnaire using a Likert scale that measured anxiety, pain, and discomfort related to each test. Additionally, the patients rated their willingness to repeat each test and how difficult each test was, compared with their expectations. ERCP was rated as having statistically significant worse pain (ERCP 2.78, MRCP 2.44), and more discomfort (ERCP 3.09, MRCP 2.47) compared with MRCP. Although not statistically significant, patients were less willing to repeat ERCP than MRCP (ERCP = −1.30, MRCP = −0.72). ERCP was found to be an easier test relative to expectations than MRCP. When patients were asked to directly compare ERCP with MRCP, ERCP was rated as more anxiety provoking, more painful, and more uncomfortable. These were all statistically significant except for the comfort domain. Patients also reported a higher preference for MRCP than ERCP.

U/S

Some discomforts associated with U/S include cold, unspecified pain, and tenderness. In a study comparing U/S with MRI in undiagnosed shoulder pain, 100% of the patients participating said that they would be willing to undergo the U/S exam again.29 This test may be preferred in pediatric patients as there is no exposure to ionizing radiation, and the test does not require sedation.

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CRITERION 7: Relative diagnostic accuracy of the test (link to definition)

A study by Banzo et al.10 evaluated the utility of hepatobiliary scintigraphy (cholescintigraphy) using 99mTc-mebrofenin for the diagnosis of bile leak in patients post liver transplant, who complained of abdominal pain after removal of the T-tube. A total of 20 patients with a mean age of 44 years old were enrolled, of which 13 were diagnosed with bile leak using cholescintigraphy, U/S, or ERCP. All 13 cases underwent cholescintigraphy; 10 cases were administered both cholescintigraphy and U/S; and six cases evaluated cholescintigraphy and ERCP. The results are presented for U/S compared with cholescintigraphy and ERCP compared with cholescintigraphy in Table 3.

Table 3. Bile Leaks Found by Cholescintigraphy Compared with Collections Identified by U/S and ERCP.

Table 3

Bile Leaks Found by Cholescintigraphy Compared with Collections Identified by U/S and ERCP.

Based on the values in Table 3, the sensitivity and specificity of U/S was 88.89% and 0%, respectively. The sensitivity for ERCP was 100% compared with cholescintigraphy. With regard to the diagnostic accuracy of cholescintigraphy, it is sensitive for detecting bile leaks, but a negative result should be an indication for an ERCP. In addition, cholescintigraphy highlights the relationship between ultrasonographic collections and the biliary system.10

Trerotola et al.5 evaluated the spectrum of biliary complications associated with laparoscopic cholecystectomy, and assessed various imaging modalities. Cases from December 1989 through July 1991 were reviewed and cholescintigraphy using 99mTc-disofenin, as well as U/S, CT, ERCP and percutaneous transhepatic cholangiography (an x-ray–based imaging modality), were included as comparators. During the review period, 13 patients were identified who met the inclusion criteria. Bile leaks were considered minor complications and detection rates were reported. The detection rates for bile leak and stricture with ERCP were reported as a combined value of 88% (7/8). All other comparators reported detection rates for bile leak independently. Cholescintigraphy detected biliary complications in 100% of cases (6/6). CT (0/4) and US (0/3) were not able to detect bile leak, as the fluid collections shown during imaging were non-specific. 5

Walker et al.20 evaluated the disruption of the bile duct and biloma after laparoscopic cholecystectomy in 1991. A total of 263 case reports of laparoscopic cholecystectomies were reviewed and seven cases of bile leak and biloma were assessed to compare the imaging evaluation of CT, U/S, ERCP, and cholescintigraphy using the radiotracer 99mTc-diisopropyliminodiacetic acid (99mTc-DISIDA). Of the seven cases, five underwent cholescintigraphy and the sensitivities for each test were calculated using cholescintigraphy as the reference standard from the information provided.20 U/S and CT scans identified fluid accumulations in the peritoneal cavity, while cholescintigraphy identified accumulations of radiolabelled bile.

Table 4. Bile Leaks Found by Cholescintigraphy Compared with Collections Identified by U/S.

Table 4

Bile Leaks Found by Cholescintigraphy Compared with Collections Identified by U/S.

In comparison to the cholescintigraphy using the radiotracer 99mTc-DISIDA, the sensitivities of U/S, CT, and ERCP were 67%, 100%, and 67%, respectively, when peritoneal fluid was used as an indicator of bile leak. If peritoneal fluid was not considered an indicator of bile leak, the respective sensitivities were 33%, 50%, and 67%. Specificity could not be calculated, as the prevalence of bile leak in the population observed was 100%.20

The authors concluded that CT and U/S were helpful in detecting abdominal fluid collections but could not differentiate bile from other fluids, while cholescintigraphy was quite useful. Cholescintigraphy would be a preferred method to ERCP as it is a non-invasive comparator; however, ERCP and percutaneous transhepatic cholangiography (PTC) may still be used to localize the exact point of leakage.20

Rayter et al.49 enrolled 35 patients undergoing elective cholecystectomy for gallstones and determined the frequency of bile leaks. After the surgery, each patient underwent cholescintigraphy and then immediately afterwards had a U/S scan. The results are presented in Table 5.

Table 5. Bile Leaks Found by HIDA Scanning Compared with Collections Identified by U/S.

Table 5

Bile Leaks Found by HIDA Scanning Compared with Collections Identified by U/S.

Based on the values in Table 5, the specificity and sensitivity of the U/S scans are 37.5% and 45.5%, respectively.

MRCP

No information was found comparing the diagnostic accuracy of MRCP with cholescintigraphy in the detection of bile leak.

Pediatric population

In 2010, Lee et al.8 conducted a retrospective review to evaluate the diagnostic usefulness of MRCP in the pediatric population where spontaneous bile duct perforation occurred. Cases from more than 10 years (March 1999 to February 2009) from a hospital database in Korea were reviewed, and three children were identified with the indication and relative comparator. MRCP was compared with U/S and cholescintigraphy using 99mTc-mebrofenin. In two of the three cases, MRCP, cholescintigraphy, and U/S were used in the detection of bile leak.

Based on the values in Table 6, the sensitivity of the U/S scan was 50% and the sensitivity for MRCP was 100% compared with cholescintigraphy. The authors concluded that U/S is the method of choice in children, but the field of view is limited. Cholescintigraphy provides useful information but exposes children to radiation and lacks anatomical information. MRCP was useful and able to detect fluid accumulation in all cases adjacent to the perforation site.

Table 6. Bile Leaks Found by Cholescintigraphy Scanning Compared with Collections Identified by U/S.

Table 6

Bile Leaks Found by Cholescintigraphy Scanning Compared with Collections Identified by U/S.

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CRITERION 8: Relative risks associated with the test (link to definition)

Non–radiation-related Risks

Cholescintigraphy

Risks associated with cholescintigraphy include allergy to HIDA, pain during cholecystokinin (CCK) injection (causes gallbladder contraction), chills, nausea, and rash.30 Rapid administration of CCK has been associated with deterioration in blood gases and respiratory function in infants.50 In a study of 18 subjects, slow infusion of CCK resulted in no adverse reactions, specifically abdominal pain, which was present in the group that had a bolus injection.50 Slow infusion of CCK is now a well-recognized practice (MIIMAC expert opinion). In susceptible subjects, CCK has induced panic attacks.50

CT

Some patients may experience an allergic reaction to the contrast agent (if required), which may worsen with repeated exposure.31 In addition, patients may experience mild side effects from the contrast agent, such as nausea, vomiting, or hives. A 2009 retrospective review of all intravascular doses of low-osmolar iodinated and Gd contrast materials administered at the Mayo Clinic between 2002 and 2006 (456,930 doses) found that 0.15% of patients given CT contrast material experienced side effects, most of which were mild. A serious side effect was experienced by 0.005% of patients.51 CT is contraindicated in patients with elevated heart rate, hypercalcemia, and impaired renal function. Specifically, Gd is contraindicated in patients with renal failure or end-stage renal disease, as they are at risk of nephrogenic systemic fibrosis. According to the American College of Radiology Manual on Contrast Media,52 the frequency of severe, life-threatening reactions with Gd is extremely rare (0.001% to 0.01%). Moderate reactions resembling an allergic response (i.e., rash, hives, urticaria) are also very unusual and range in frequency from 0.004% to 0.7%.52

ERCP

ERCP is an invasive endoscopy-based procedure and can lead to further complications.32 Prolonged cannulation may cause additional morbidity to patients and unnecessary radiation exposure.33 ERCP is also associated with a high morbidity rate. In an uncontrolled prospective study conducted by Christensen, the procedure-related mortality rate was 1.0% in a population of 1,177 procedures, and overall 30-day mortality was 5.8%. Morbidity-related complications occurring in 15.8% of the population included pancreatitis, hemorrhage, perforation, cholangitis, perforated stent, and complications related to cardiac, respiratory, and thromboembolic systems.34

MRI

MRI is contraindicated in patients with metallic implants, including pacemakers.35 MRI is often used in conjunction with the contrast agent Gd. Some patients may experience an allergic reaction to the contrast agent (if required), which may worsen with repeated exposure.31 Side effects of Gd include headaches, nausea, and metallic taste. Gd is contraindicated in patients with renal failure or end-stage renal disease, as they are at risk of nephrogenic systemic fibrosis. According to the American College of Radiology Manual on Contrast Media,52 the frequency of severe, life-threatening reactions with Gd is extremely rare (0.001% to 0.01%). Moderate reactions resembling an allergic response (i.e., rash, hives, urticaria) are also very unusual and range in frequency from 0.004% to 0.7%.52

U/S

There are no reported risks associated with U/S in the literature that was reviewed.

Radiation-related Risks

Among the modalities to diagnose bile leak, cholescintigraphy, CT, and ERCP expose the patient to ionizing radiation. The average effective dose of radiation delivered with each of these procedures can be found in Table 7.

Table 7. Effective Radiation Doses for Various Imaging Tests.

Table 7

Effective Radiation Doses for Various Imaging Tests.

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CRITERION 9: Relative availability of personnel with expertise and experience required for the test (link to definition)

Cholescintigraphy

In Canada, physicians involved in the performance, supervision, and interpretation of hepatobiliary scans should be nuclear medicine physicians or diagnostic radiologists with training or expertise in nuclear imaging.53 Physicians should have a Fellowship of Certification in Nuclear Medicine or Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Nuclear medicine technologists are required to conduct cholescintigraphy. Technologists must be certified by the Canadian Association of Medical Radiation Technologists (CAMRT) or an equivalent licensing body.

All alternative imaging modalities

In Canada, physicians involved in the performance, supervision, and interpretation of diagnostic CT scans, MRI, and U/S should be diagnostic radiologists41 and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Foreign-trained radiologists also are qualified if they are certified by a recognized certifying body and hold a valid provincial license.53

Service engineers are needed for system installation, calibration, and preventive maintenance of the imaging equipment at regularly scheduled intervals. The service engineer’s qualification will be ensured by the corporation responsible for service and the manufacturer of the equipment used at the site.

Qualified medical physicists (on-site or contracted part-time) should be available for the installation, testing, and ongoing quality control of CT scanners, MR scanners, and nuclear medicine equipment.53

CT

For the performance of CT scan, medical radiation technologists who are certified by CAMRT, or an equivalent licensing body recognized by CAMRT, are required. The training of technologists specifically engaged in CT should meet with the applicable and valid national and provincial specialty qualifications.

ERCP

ERCP is an x-ray–based test performed by gastroenterologists. Gastroenterologists must have certification from the Royal College of Physicians and Surgeons of Canada (or Collège des médecins du Québec). ERCP is performed mostly by gastroenterologists with advanced endoscopy training, lasting one or two years after completion of the mandatory two-year subspecialty program.54

Expert endoscopists have a higher rate of successful cannulation, while novices have lower success rates and increased complication rates.16

Jowell et al.55 completed a study evaluating the competency of gastroenterology fellows (at various stages of training) to complete an ERCP. Fellows performed this procedure under the watchful eye of an experienced therapeutic endoscopist. The fellows were graded on various technical aspects of the procedure, using a five-point scale: 1-excellent; 2-adequate; 3-partially successful; 4-failed; 5-no attempt. If the fellow achieved a score of 1 or 2, this was considered acceptable. Adequate skill in a particular component of the exam was arbitrarily defined as reflecting competency if the probability of an acceptable score was 0.8. The results of this study state that 160 ERCPs have to be done before a fellow achieves adequate skills. A more recent report states that the Canadian Association of Gastroenterology recommends at least 180 procedures should be performed before competence can be assessed.56 According to the Endoscopy Committee of the Canadian Association of Gastroenterology, ERCP is one of the most technically demanding and highest-risk procedures performed by endoscopists.54

MRCP

Medical technologists must have CAMRT certification in magnetic resonance or be certified by an equivalent licensing body recognized by CAMRT.

U/S

Sonographers (or ultrasonographers) should be graduates of an accredited school of sonography or have obtained certification from the Canadian Association of Registered Diagnostic Ultrasound Professionals. They should be members of their national or provincial professional organization. Sonography specialties include general sonography, vascular sonography, and cardiac sonography.41 In Quebec, sonographers and medical radiation technologists are grouped together; in the rest of Canada, sonographers are considered a distinct professional group.41

The availability of expertise to image bile leak varies across the jurisdictions. Table 8 reports the number of medical imaging professionals nationally and highlights those provinces and territories that lack a specific expertise. Gastroenterologists are not included in this list; however, the number of gastroenterologists in Canada available to perform the procedure is reported to be 1.83 per 100,000 persons.57

Table 8. Medical Imaging Professionals in Canada.

Table 8

Medical Imaging Professionals in Canada.

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CRITERION 10: Accessibility of alternative tests (equipment and wait times) (link to definition)

There are notable variations in the availability of medical imaging technologies across Canada. Table 9 provides an overview of the availability of equipment required to diagnose bile leak. Data for nuclear medicine cameras (including SPECT) are current to January 1, 2007. The number of CT, MRI, and SPECT/CT scanners is current to January 1, 2010. Data were not available for U/S.

Table 9. Diagnostic Imaging Equipment in Canada.

Table 9

Diagnostic Imaging Equipment in Canada.

Cholescintigraphy

To perform cholescintigraphy, nuclear medicine facilities with gamma cameras (including SPECT) are required. Three jurisdictions, the Yukon, the Northwest Territories, and Nunavut, do not have any nuclear medicine equipment.41

CT

No CT scanners are available in Nunavut.42 The average weekly use of CT scanners ranged from 40 hours in PEI to 69 hours in Ontario, with a national average of 60 hours.41 In 2010, the average wait time for a CT scan in Canada is 4.2 weeks.43

ERCP

ERCP is an x-ray–based test. X-ray machines are widely available across the country.

MRCP

MRCP is an MRI based test. No MRI scanners available in the Yukon, Northwest Territories, or Nunavut.42 According to CIHI’s National Survey of Selected Medical Imaging Equipment database, the average number of hours of operation per week for MRI scanners in 2006–2007 ranged from 40 hours in PEI to 99 hours in Ontario with a national average of 71 hours.41 In 2010, the average wait time for MR imaging in Canada was 9.8 weeks.43

U/S

U/S machines are widely available across the country. According to the Fraser Institute, the average wait time for U/S in 2010 was 4.5 weeks.43

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CRITERION 11: Relative cost of the test (link to definition)

Fee codes from the Ontario Schedule of Benefits were used to estimate the relative costs of cholescintigraphy and its alternatives. Technical fees are intended to cover costs incurred by the hospital (i.e., radiopharmaceutical costs, medical/surgical supplies, and non-physician salaries). Maintenance fees are not billed to OHIP — estimates here were provided by St. Michael’s Hospital in Toronto. Certain procedures (i.e., PET scan, CT scan, MRI scan) are paid for, in part, out of the hospital’s global budget; these estimates were provided by The Ottawa Hospital. It is understood that the relative costs of imaging will vary from one institution to the next.

According to our estimates (Table 9), the cost of cholescintigraphy with 99mTc-based radioisotopes is $247.85. CT is minimally more costly, MRCP is moderately more costly, and U/S is minimally less costly than cholescintigraphy. An estimate for ERCP could not be obtained; however, actual costs (i.e., excluding professional fees) obtained from one Ontario hospital were reported to be approximately $1900. Therefore, ERCP is a significantly more costly alternative.

Table 9. Cost Estimates Based on the Ontario Schedule of Benefits for Physician Services Under the Health Insurance Act (September 2011).

Table 9

Cost Estimates Based on the Ontario Schedule of Benefits for Physician Services Under the Health Insurance Act (September 2011).

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APPENDICES

Appendix 1. Multi-Criteria Decision Analysis Definitions

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Appendix 2. Literature Search Strategy

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Appendix 3. Definitions

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