Pancreatic Surgery Clinical Trial
— PREFIPSOfficial title:
Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study
Verified date | April 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
Status | Completed |
Enrollment | 655 |
Est. completion date | February 9, 2021 |
Est. primary completion date | February 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men or women aged 18 years or greater - Signed informed consent - Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy Exclusion Criteria: - Patient with radiation therapy - Patient with neoadjuvant chemotherapy within 4 weeks before surgery - Pregnancy - Breastfeeding - Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator - Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion - Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (LAR) or s.c. formulations - Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations - Patients treated by ciclosporin - Patient without health insurance or social security - Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study |
Country | Name | City | State |
---|---|---|---|
France | Cochin Hospital | Paris | |
France | La Pitié Salpêtrière Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | = grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification | 90 days | ||
Secondary | =grade 3 pancreatic complication rates (fistula, leak, and abscess) | as defined by the MSKCC surgical secondary events system | 60 days | |
Secondary | Overall pancreatic fistula rate (grade A,B and C) | previous ISGPF classification | 90 days | |
Secondary | Overall pancreatic fistula rate (grade B and C) | last ISGPF classification | 90 days | |
Secondary | Overall complication rate (grade 1 to 5) | according to Clavien-Dindo classification | 90 days | |
Secondary | Severe complication rate (grade 3 to 5) | according to Clavien-Dindo classification | 90 days | |
Secondary | Mortality (grade 5) | according to Clavien-Dindo classification | 90 days | |
Secondary | Overall duration of drainage | required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed) | 90 days | |
Secondary | Overall length of stay | 90 days | ||
Secondary | Re-admission rate | 90 days | ||
Secondary | Cost effectiveness | 90 days | ||
Secondary | Fistula according to possible new definition of the ISGPF group | 90 days | ||
Secondary | Postoperative quality of life after pancreatic surgery | only in patients undergoing pancreaticoduodenectomy | 7 days after surgery |
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