Clinical trial to compare duodenum preserving pancreatic head resection according to Beger versus the Berne modification in patients with chronic pancreatitis: a randomised controlled trial

Completed

Conditions: Chronic pancreatitis
Digestive System
Other Chronic pancreatitis

Registration Number: ISRCTN50638764

Lead Sponsor: niversity of Heidelberg Medical School (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 65

Inclusion Criteria

Patients undergoing elective duodenum-preserving pancreatic head resection due to chronic pancreatitis.

Eligibility criteria:
1. Patients of any age (greater than 18 years)
2. Expected survival time more than 24 months
3. Informed consent

Exclusion Criteria

1. Participation in another intervention trial that would interfere with the intervention and outcome of this study
2. Severe psychiatric disorders or neurological diseases
3. Lack of compliance
4. Drug and/or alcohol abuse according to local standards

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is combined out of four components. In order to adjust for multiple testing a hierarchical model is used.<br><br>1. Duration of surgical procedure [min]<br>2. Quality of life (EORTC QLQ-C30 questionnaire and the disease specific module for pancreatic diseases EORTC QLQ-PAN26) at 12 months after the intervention<br>3. Duration of stay on the intensive care unit<br>4. Duration of postoperative hospital stay

Secondary Outcome Measures

Name	Time	Method
Frequencies of early and late onset complications such as intra- or postoperative bleeding with subsequent need for blood transfusion, pancreatic fistula, postoperative pulmonary complications, wound infections and re-laparotomy; exocrine and endocrine pancreatic function as determined by levels of HbA1c and stool elastase.<br><br>