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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-11062 | Registry Identifier | NCI |
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study paused for interim analysis
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This phase II/III trial compares the effect octreotide and the duration of antibiotic treatment has on outcomes in patients undergoing a Whipple procedure. A Whipple procedure is a surgery that may remove all or part of the pancreas, part of the intestines, stomach and gallbladder. Leakage from the pancreas due to damaged pancreatic ducts (fistula) is a major complication following pancreatic resection often delaying further treatment and increasing hospital stays. Antibiotics along with octreotide, which works by inhibiting pancreatic secretions, is standard treatment for a pancreatic fistula. This study will determine if the length of antibiotic treatment decreases the rate of fistulas and shortens hospital stays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Active somatostatin analogue combined with perioperative antibiotics |
|
| Group 2 | Placebo Comparator | Placebo combined with perioperative antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatostatin analog | Drug | Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Assessed by the length of hospital stay (days) following pancreatic surgery. | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pancreatic fistula | defined as postoperative drain output of fluid with amylase content more than 3 times the maximum normal serum value and exceeding 10 mL/24 h for more than 3 days | Up to 90 days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Kendrick, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2022 | Feb 25, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2024 | Feb 25, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013004 | Somatostatin |
| ID | Term |
|---|---|
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
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Patients will be randomized on a 1:1 ratio to either somatostatin analogues with perioperative antibiotics vs. placebo with perioperative antibiotics
| 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 |