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Lancet. 2017 Sep 9;390(10099):1027-1037. doi: 10.1016/S0140-6736(17)31960-8.

Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: the multicentre, randomised, controlled, double-blind ChroPac trial.

Author information

1
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany; Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany.
2
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
3
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
4
Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany.
5
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Technical University Dresden, Dresden, Germany.
6
Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
7
Department of General and Visceral Surgery, Medical Centre, University of Freiburg, Freiburg, Germany.
8
Department of Surgery, University Hospital Rechts der Isar, Technical University Munich, Munich, Germany.
9
Department of Visceral, Transplantation, Thoracic, and Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.
10
Department of General, Visceral, Vascular and Transplantation Surgery, University of Munich, Munich, Germany.
11
Department of General, Visceral, Thoracic and Vascular Surgery, Universitätsmedizin Greifswald, Greifswald, Germany.
12
Department of Abdominal Surgery, University Medical Centre, Ljubljana, Slovenia.
13
NIHR Pancreas Biomedical Research Unit, Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
14
Department of Surgery, University Medical Centre Mannheim (UMM), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
15
Charité, Department of Surgery, CCM/CVK Berlin, Berlin, Germany.
16
Department of General, Visceral, Thoracic, and Trauma Surgery, Krankenhaus der Augustinerinnen, Cologne, Germany.
17
Department of Surgery, University Medical Center Regensburg, Regensburg, Germany.
18
Department for General, Visceral, Vascular, and Pediatric Surgery, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg, Germany.
19
Department of General, Visceral, Vascular, and Pediatric Surgery, University Hospital Würzburg, Würzburg, Germany.
20
Department of General and Visceral Surgery, Red Cross Hospital Munich, Munich, Germany.
21
Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.
22
Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany.
23
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany; The Surgical Trial Network CHIR-Net, University of Heidelberg, Heidelberg, Germany.
24
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany. Electronic address: markus.buechler@med.uni-heidelberg.de.

Abstract

BACKGROUND:

There is substantial uncertainty regarding the optimal surgical treatment for chronic pancreatitis. Short-term outcomes have been found to be better after duodenum-preserving pancreatic head resection (DPPHR) than after partial pancreatoduodenectomy. Therefore, we designed the multicentre ChroPac trial to investigate the long-term outcomes of patients with chronic pancreatitis within 24 months after surgery.

METHODS:

This randomised, controlled, double-blind, parallel-group, superiority trial was done in 18 hospitals across Europe. Patients with chronic pancreatitis who were planned for elective surgical treatment were randomly assigned to DPPHR or partial pancreatoduodenectomy with a central web-based randomisation tool. The primary endpoint was mean quality of life within 24 months after surgery, measured with the physical functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Primary analysis included all patients who underwent one of the assigned procedures; safety analysis included all patients who underwent surgical intervention (categorised into groups as treated). Patients and outcome assessors were masked to group assignment. The trial was registered, ISRCTN38973832. Recruitment was completed on Sept 3, 2013.

FINDINGS:

Between Sept 10, 2009, and Sept 3, 2013, 250 patients were randomly assigned to DPPHR (n=125) or partial pancreatoduodenectomy (n=125), of whom 226 patients (115 in the DPPHR group and 111 in the partial pancreatoduodenectomy group) were analysed. No difference in quality of life was seen between the groups within 24 months after surgery (75·3 [SD 16·4] for partial pancreatoduodenectomy vs 73·0 [16·4] for DPPHR; mean difference -2·3, 95% CI -6·6 to 2·0; p=0·284). The incidence and severity of serious adverse events did not differ between the groups. 70 (64%) of 109 patients in the DPPHR group and 61 (52%) of 117 patients in the partial pancreatoduodenectomy group had at least one serious adverse event, with the most common being reoperations (for reasons other than chronic pancreatitis), gastrointestinal problems, and other surgical morbidity.

INTERPRETATION:

No differences in quality of life after surgery for chronic pancreatitis were seen between the interventions. Results from single-centre trials showing superiority for DPPHR were not confirmed in the multicentre setting.

FUNDING:

German Research Foundation (DFG).

PMID:
28901935
DOI:
10.1016/S0140-6736(17)31960-8
[Indexed for MEDLINE]

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