Distal Pancreatectomy: a randomised controlled trial to compare two different surgical techniques
- Conditions
- Diseases of the pancreatic body and tailDigestive SystemOther diseases of pancreas
- Registration Number
- ISRCTN18452029
- Lead Sponsor
- niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 450
1. Age equal or above 18 years
2. Expected survival time more than 12 months
3. Patients with at least one of the following pathologic diseases scheduled for elective resection:
3.1. Resectable malignancies of the pancreatic body and/or tail
3.2. Resectable chronic pancreatitis of the body and/or tail
3.3. Resectable benign tumours of the pancreas including neuroendocrine tumours
3.4. Resectable pseudocyst of the pancreatic body and/or tail
1. Current immunosuppressive therapy
2. Chemotherapy within two weeks before operation
3. Radiotherapy within eight weeks before operation
4. Curative resection is not feasible
5. Severe psychiatric or neurologic diseases
6. Drug and/or alcohol abuse according to local standards
7. Participation in another intervention trial with interference of intervention or outcome
8. Inability to follow the instructions given by the investigator or interviewer
9. Expected lack of compliance
10. Lack of informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The combined primary endpoint is the presence of a pancreatic fistula and/or death due to any cause on day seven post-operatively.
- Secondary Outcome Measures
Name Time Method 1. Operating time<br>2. Frequencies of burst abdomen, wound infection, and intra-abdominal fluid collection and abscess<br>3. Post-operative length of hospital stay<br>4. New onset of diabetes mellitus<br>5. One-year survival