Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head

Conditions

Chronic pancreatitis Digestive System Other diseases of pancreas

Diener MK, Hüttner FJ, Kieser M, Knebel P, Dörr-Harim C, Distler M, Grützmann R, Wittel UA, Schirren R, Hau HM, Kleespies A, Heidecke CD, Tomazic A, Halloran CM, Wilhelm TJ, Bahra M, Beckurts T, Börner T, Glanemann M, Steger U, Treitschke F, Staib L, Thelen K, Bruckner T, Mihaljevic AL, Werner J, Ulrich A, Hackert T, Büchler MW, ChroPac Trial Group.

2017-09-01102 citations

10.1016/s0140-6736(17)31960-8

ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial.

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM.

2010-04-2920 citations

10.1186/1745-6215-11-47

Interventions

Experimental intervention: Any surgical technique that removes inflamed pancreatic tissue of the head without resection of the duodenum (e.g. Beger, Frey or Berne procedure). Control intervention:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients (no age or gender restrictions) with chronic pancreatitis of the head and pain, eligible for elective surgical resection 2. Ability of subject to understand character and individual consequences of the clinical trial 3. Written informed consent

Exclusion criteria

Exclusion criteria: Participation in another intervention-trial with interference of intervention and outcome of this study

Design outcomes

Primary

Measure	Time frame
Average QoL during 24 months after surgery, measured 6, 12 and 24 months after surgery by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) scale "physical functioning". The primary efficacy analysis will be conducted for the intention-to-treat population. An analysis of covariance (ANCOVA) model will be applied for the intervention group comparison adjusting for age, centre and EORTC QLQ-C30 scale "physical functioning" before surgery. The level of significance is set at 5% (two-sided) and sample size is determined to assure a power of 1-beta = 90%.	—

Measure

Time frame

Average QoL during 24 months after surgery, measured 6, 12 and 24 months after surgery by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) scale "physical functioning". The primary efficacy analysis will be conducted for the intention-to-treat population. An analysis of covariance (ANCOVA) model will be applied for the intervention group comparison adjusting for age, centre and EORTC QLQ-C30 scale "physical functioning" before surgery. The level of significance is set at 5% (two-sided) and sample size is determined to assure a power of 1-beta = 90%.

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Secondary

Measure	Time frame
Exploratory analyses	—

Countries

Germany, Netherlands, Slovenia, United Kingdom

Outcome results

None listed