ChroPac-TrialDuodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head. A randomized controlled multicentre trial

Not Applicable

• Conditions: chronic pancreatitis; K86.0; K86.1; Alcohol-induced chronic pancreatitis; Other chronic pancreatitis

• Registration Number: DRKS00000167
• Lead Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Study Completion: 2015-09-02
• Results First Posted: 2017-09-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

patients with chronic pancreatitis of the head and pain eligible for elective surgical resection
-ability of subject to understand character and individual consequences of the clinical trial
- written informed consent

Exclusion Criteria

participation in another intervention-trial with interference of intervention and outcome of this study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average Quality of life during 24 months after surgery, measured 6,12 and 24 months after surgery by the EORTC QLQ-C30 scale physical functioning.

Secondary Outcome Measures

Name	Time	Method
Mortality/Morbidity/EORTC QLQ-C30 and PAN 26 (CP) subscores/initial postoperative hospital stay after randomization/total hospital stay due to chronic pancreatitis within 24 months after randomization/Reoperation due to recurrence of chronic pancreatitis/Weight gain/New onset of diabetes mellitus requiring treatment/Development of exocrine insufficiency/operation time/Blood loss assessed by surgeons and anesthesists