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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001673-32 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatostatin | Experimental | Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days |
|
| Octreotide | Active Comparator | Subcutaneous octreotide 100 μg 3 times a day for 6.5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatostatin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| ≥grade 3 pancreatic complication rates (fistula, leak, and abscess) | as defined by the MSKCC surgical secondary events system | 60 days |
| Overall pancreatic fistula rate (grade A,B and C) | previous ISGPF classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien GAUJOUX, MD, PhD | La Pitié Salpêtrière Hospital, AP-HP | Principal Investigator |
| Bertrand DOUSSET, MD, PhD | Cochin Hospital, AP-HP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | Paris | 75014 | France | ||
| La Pitié Salpêtrière Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38662619 | Result | Gaujoux S, Regimbeau JM, Piessen G, Truant S, Foissac F, Barbier L, Buc E, Adham M, Fuks D, Deguelte S, Muscari F, Sulpice L, Vaillant JC, Schwarz L, Sa Cunha A, Muzzolini M, Dousset B, Sauvanet A; Collaborators. Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study. Ann Surg. 2024 Aug 1;280(2):179-187. doi: 10.1097/SLA.0000000000006313. Epub 2024 Apr 25. |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D013004 | Somatostatin |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Octreotide | Drug | Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days |
|
|
| 90 days |
| Overall pancreatic fistula rate (grade B and C) | last ISGPF classification | 90 days |
| Overall complication rate (grade 1 to 5) | according to Clavien-Dindo classification | 90 days |
| Severe complication rate (grade 3 to 5) | according to Clavien-Dindo classification | 90 days |
| Mortality (grade 5) | according to Clavien-Dindo classification | 90 days |
| Overall duration of drainage | required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed) | 90 days |
| Overall length of stay | 90 days |
| Re-admission rate | 90 days |
| Cost effectiveness | 90 days |
| Fistula according to possible new definition of the ISGPF group | 90 days |
| Postoperative quality of life after pancreatic surgery | only in patients undergoing pancreaticoduodenectomy | 7 days after surgery |
| Paris |
| 75013 |
| France |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010187 | Pancreatic Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |