MedDataX Logo

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

NCT ID: NCT02178319

Last Updated: 2014-06-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Portal Hypertension Liver Cirrhosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

portal hypertension Randomized clinical trial laparoscopic open

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

open group

the patients under go the open esophagogastric devascularization and splenectomy

Group Type ACTIVE_COMPARATOR

open surgical procedure

Intervention Type PROCEDURE

open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

laparoscopic group

the patients under go the laparoscopic esophagogastric devascularization and splenectomy

Group Type EXPERIMENTAL

laparoscopic surgical procedure

Intervention Type PROCEDURE

laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

open surgical procedure

open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

Intervention Type PROCEDURE

laparoscopic surgical procedure

laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine

Xi'an, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yang Liu, Doctor

Role: CONTACT

Phone: +86-29-87679246

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yang Liu, Doctor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

portal hypertension

Identifier Type: -

Identifier Source: org_study_id