Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial

June 26, 2014 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

Randomized Clinical Trial Comparing Laparoscopic and Open Esophagogastric Devascularization and Splenectomy for Portal Hypertension

Many patients with portal hypertension require surgical treatment each year,and Hassab's operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to treat portal hypertension. However, the potential benefits remain to be demonstrated in the context of a randomized trial. In this study, 120 patients will randomize equally receiving laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria included: platelet count < 50×109/ml, esophageal and gastric varices revealed, agreeing the informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux on duplex ultrasound examination, complications, platelet and liver function variation, length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xi'an, China, 710004
        • Recruiting
        • Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The cause of portal hypertension was cirrhosis
  • Platelet count < 50×109/ml
  • Esophageal and gastric varices revealed
  • Agreeing the informed consent.

Exclusion Criteria:

  • Thrombosis present in portal vein preoperatively
  • Accompany with liver cancer
  • Operation procedure is laparoscopy converse to open
  • Patients disagree with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open group
the patients under go the open esophagogastric devascularization and splenectomy
Procedure: open surgical procedure
open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
Experimental: laparoscopic group
the patients under go the laparoscopic esophagogastric devascularization and splenectomy
Procedure: laparoscopic surgical procedure
laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 5 years
gastroesophageal varices recurrence rate
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: 1 day
Duration of surgical procedure
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: 4 weeks
4 weeks
blood loss during surgical procedure
Time Frame: 1 day
1 day
blood transfusion during surgical procedure
Time Frame: 1 day
1 day
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 4 weeks
record all kind of postoperative complications in each patient
4 weeks
rebleeding
Time Frame: 1 day
record rebleeding time in each bleeding patient
1 day
cost of hospitalization
Time Frame: 4 weeks
4 weeks
survival
Time Frame: 5 years
record the time of death and the death reason
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • portal hypertension

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Clinical Trials on open surgical procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe