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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000946
Other study ID # P150915
Secondary ID 2016-001673-32
Status Completed
Phase Phase 3
First received
Last updated
Start date May 15, 2017
Est. completion date February 9, 2021

Study information

Verified date April 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula


Description:

Prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results. Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection. In view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention. Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Somatostatin
Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days
Octreotide
Solution for Subcutaneous use 100µg, every 8 hours Subcutaneous injection for 6,5 days

Locations

Country Name City State
France Cochin Hospital Paris
France La Pitié Salpêtrière Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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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