NCT03179995

Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Liver Resection

Interventions

Type	Name	Description
DRUG	Octreotide	Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
OTHER	Placebo	Normal saline will be administered in the same fashion as Octreotide

Timeline

• Start date: 2017-07-07
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2017-06-07
• Last updated: 2024-02-14
• Results posted: 2022-05-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study