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

Xi'an Jiaotong University

Status: Unknown

Conditions: Portal Hypertension; Liver Cirrhosis

Treatments: Procedure: laparoscopic surgical procedure; Procedure: open surgical procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02178319

portal hypertension

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

open group

Active Comparator group

Description:

the patients under go the open esophagogastric devascularization and splenectomy

Treatment:

Procedure: open surgical procedure

laparoscopic group

Experimental group

Description:

the patients under go the laparoscopic esophagogastric devascularization and splenectomy

Treatment:

Procedure: laparoscopic surgical procedure