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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000005
Enrollment
450
Registered
2008-08-08
Start date
2007-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

5-524: null C25 K86.3 K86.1

Interventions

Group 1: Control group: Scalpel resectioning and manual closing of suture Group 2: Experimental group: Resectioning and closing with stapler

Sponsors

Universitätsklinikum Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Belgium, Germany, Italy, Netherlands, Slovenia, United Kingdom

Contacts

Public ContactInga Rossion

Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universität Heidelberg

inga.rossion@med.uni-heidelberg.de+49 6221 56-6984

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026