Distal Pancreatectomy: a randomised controlled trial to compare two different surgical techniques

Conditions

Diseases of the pancreatic body and tail Digestive System Other diseases of pancreas

Zimmermann JB, Lehmann M, Hofer S, Hüsing J, Alles C, Werner J, Stiller J, Künnecke W, Luntz S, Motsch J, Weigand MA.

2012-09-224 citations

Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.

Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Büchler MW.

2011-04-01371 citations

10.1016/s0140-6736(11)60237-7

Interventions

Distal pancreatectomy: 1. Experimental group: stapler resection 2. Control group: scalpel resection and hand-suture of the pancreatic stump

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The combined primary endpoint is the presence of a pancreatic fistula and/or death due to any cause on day seven post-operatively.	—

Secondary

Measure	Time frame
1. Operating time 2. Frequencies of burst abdomen, wound infection, and intra-abdominal fluid collection and abscess 3. Post-operative length of hospital stay 4. New onset of diabetes mellitus 5. One-year survival	—

Countries

Germany, Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom

Outcome results

None listed