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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178319
• Other study ID #: portal hypertension
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2014
• Last updated: June 26, 2014
• Start date: June 2014
• Est. completion date: September 2021

Study information

• Verified date: June 2014
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Yang Liu, Doctor
• Phone: +86-29-87679246
• Email: individualliu[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Procedure:
• open surgical procedure
open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
• laparoscopic surgical procedure
laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

Locations

Country	Name	City	State
China	Department of General Surgery , Second Af?liated Hospita l, Xi'an Jiaotong Universi ty School of Medicine	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood loss during surgical procedure		1 day	Yes
Other	blood transfusion during surgical procedure		1 day	Yes
Other	Number of Participants with Serious and Non-Serious Adverse Events	record all kind of postoperative complications in each patient	4 weeks	Yes
Other	rebleeding	record rebleeding time in each bleeding patient	1 day	Yes
Other	cost of hospitalization		4 weeks	Yes
Other	survival	record the time of death and the death reason	5 years	Yes
Other	length of hospital stay		4 weeks	Yes
Primary	recurrence	gastroesophageal varices recurrence rate	5 years	Yes
Secondary	operation time	Duration of surgical procedure	1 day	Yes