Diener, Markus K. and Huettner, Felix J. and Kieser, Meinhard and Knebel, Phillip and Doerr-Harim, Colette and Distler, Marius and Gruetzmann, Robert and Wittel, Uwe A. and Schirren, Rebekka and Hau, Hans-Michael and Kleespies, Axel and Heidecke, Claus-Dieter and Tomazic, Ales and Halloran, Christopher M. and Wilhelm, Torsten J. and Bahra, Marcus and Beckurts, Tobias and Boerner, Thomas and Glanemann, Matthias and Steger, Ulrich and Treitschke, Frank and Staib, Ludger and Thelen, Karsten and Brueckner, Thomas and Mihaljevic, Andre L. and Werner, Jens and Ulrich, Alexis and Hackert, Thilo and Buechler, Markus W. (2017) Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: the multicentre, randomised, controlled, double-blind ChroPac trial. LANCET, 390 (10099). pp. 1027-1037. ISSN 0140-6736, 1474-547X
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | QUALITY-OF-LIFE; INTERNATIONAL STUDY-GROUP; INTENTION-TO-TREAT; WHIPPLE PROCEDURE; FOLLOW-UP; DRAINAGE; SURGERY; QLQ-C30; METAANALYSIS; DEFINITION; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 13:15 |
| Last Modified: | 19 Feb 2019 10:54 |
| URI: | https://pred.uni-regensburg.de/id/eprint/1189 |
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