DISPACT: Distal Pancreatectomy - A randomized controlled trial to compare two different surgical techniques

• Conditions: 5-524: null; C25; K86.3; K86.1; Malignant neoplasm of pancreas; Pseudocyst of pancreas; Other chronic pancreatitis

• Registration Number: DRKS00000005
• Lead Sponsor: niversitätsklinikum HeidelbergStudienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-08
• Study Completion: 2009-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Age equal or above 18 years
-Expected survival time more than 12 month
-Patients with at least one of the following pathologic diseases scheduled for elective resection:
*Resectable malignancies of pancreatic body and/or tail
*Resectable chronic pancreatitis of the body and/or tail
*Resectable benigne tumours of the pancreas including neuroendocrine tumours
*Resectable pseudocyst of the pancreatic body and/or tail

Exclusion Criteria

-Current immunosuppressive therapy
-Chemotherapy within 2 weeks before operation
-Radiotherapy within 8 weeks before operation
-Curative resecion is not feasible
-Severe psychiatric or neurologic diseases
-Drug- and/or alcohol-abuse according to local standarts
-Participation in another intervention trial with interference of intervention or outcome
-Inability to follow instructions given by the investigator or interviewer
-Expected lack of compliance
-Lack of informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined primary endpoint: presence of a pancreatic fistula and / or death due to any cause on day 7 postoperatively.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: operating time, frequency of burst abdomen, wound infection, and intraabdominal fluid collection and abscess, postoperative length of hospital stay, new onset of diabetes mellitus, one-year survival.