Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2024-04-30

Brief Summary

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Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day

Group Type EXPERIMENTAL

somatostatin infusion

Intervention Type DRUG

postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.

Control group

Placebo infusion (50ml of 0.9% NaCl/day) during 6 days

Group Type PLACEBO_COMPARATOR

placebo infusion

Intervention Type DRUG

Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.

Interventions

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somatostatin infusion

postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.

Intervention Type DRUG

placebo infusion

Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with HCC diagnosed by histology or by imaging findings according to the Barcelona Clinic Liver Cancer Group
* Patients with a single or multiple HCCs deemed to be resectable with a curative intent at the preoperative evaluation
* Patients for whom an indication for hepatectomy has been decided and approved by multidisciplinary board:
* by laparotomy
* by coelioscopy with resection of at least 2 liver segments
* Patients with any underlying liver disease with or without proven cirrhosis, regarding histological features (including F2-F3-F4 fibrosis with or without cirrhosis) or with other evidence of a diseased liver if no biopsy has been performed preoperatively (dysmorphic liver or evidence of portal hypertension at imaging findings, oesophageal varices at endoscopy)
* Age ≥ 18 years
* Patients with ability to understand and sign a written inform consent form
* Patients who will be available for follow-up

* Another histologic type of hepatic tumor besides HCC
* Distant extra-hepatic metastases, including peritoneal carcinomatosis
* The existence of complete portal thrombosis of the main portal trunk

\- Indication of coelioscopy with resection of less than 2 liver segments

Exclusion Criteria

* Patients participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgement criteria of the study according to the judgement of the coordinating investigator).
* Patients with evidence of a healthy liver at biopsy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No