Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-07 @ 7:03 AM
Study NCT ID:
NCT03179995
Status:
TERMINATED
Last Update Posted:
2024-02-14
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Grantor closed study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a prospective, randomized, double blind trial enrolling patients who will undergo major liver resection. Patients will be randomized in a 1:1 ratio to receive either octreotide or placebo in the postoperative period. The patients will receive octreotide intravenously continuously for five days after operation. During this period the patients' health will be monitored by performing blood tests including complete metabolic profile, Complete Blood Count (CBC) with/diff., INR and PTT. The functioning of heart will also be monitored post-operatively by EKG. Up to 80 participants will be accrued over a 2 year period. Volumetric CT scans will be performed prior to hepatectomy, 1 week after hepatectomy and 3 months after hepatectomy to evaluate liver regeneration.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GI-072 | OTHER | Fox Chase Cancer Center | View |