Closure of the Pancreatic Remnant after Distal Pnacreatectomy A prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24836

Enrollment

250

Registered

2016-09-08

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

chronic pancreatitis, cystic pancreatic lesions, malignant pancreatic lesions and neuroendocrine tumors located in the body or tail of the pancreas.

Interventions

placement of a collagen patch on the sutured or stapled pancreatic remnant, with a sutured/stapled closed pancreatic remnant as control.

Eligibility

Inclusion criteria

Inclusion criteria: - Age above 18 years - Expected survival time more than 12 months - WHO Karnofsky performance status >50% / ASA I-II - Patients with chronic pancreatitis, cystic pancreatic lesions, malignant pancreatic lesions and neuroendocrine tumors located in the body or tail of the pancreas. - patients who are planned to undergo distal pancreatectomy as part of an extensive resection for other malignancies (i.e. sarcoma, GIST, gastric carcinoma). - written informed consent

Exclusion criteria

Exclusion criteria: - Current immunosuppresive therapy - Chemotherapy within 2 weeks before operation - Curative resection not feasable - Severe psychiatrric or neurologic disease - Drug and/or alcohol abuse

Design outcomes

Primary

Measure	Time frame
development of pancreatic fistula	—

Secondary

Measure	Time frame
mortality morbidity costs	—

Contacts

Public ContactC.H.J. van Eijck

Erasmus MC, department of Surgery

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)