NCT02178319

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

7 years

First QC Date

June 19, 2014

Last Update Submit

June 26, 2014

Conditions

Portal HypertensionLiver Cirrhosis

Keywords

portal hypertensionRandomized clinical triallaparoscopicopen

Outcome Measures

Primary Outcomes (1)

  • recurrence

    gastroesophageal varices recurrence rate

    5 years

Secondary Outcomes (1)

  • operation time

    1 day

Other Outcomes (7)

  • blood loss during surgical procedure

    1 day

  • blood transfusion during surgical procedure

    1 day

  • Number of Participants with Serious and Non-Serious Adverse Events

    4 weeks

  • +4 more other outcomes

Study Arms (2)

open group

ACTIVE COMPARATOR

the patients under go the open esophagogastric devascularization and splenectomy

Procedure: open surgical procedure

laparoscopic group

EXPERIMENTAL

the patients under go the laparoscopic esophagogastric devascularization and splenectomy

Procedure: laparoscopic surgical procedure

Interventions

open surgical procedurePROCEDURE

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

open group
laparoscopic surgical procedurePROCEDURE

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

laparoscopic group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Xi'an, 710004, China

RECRUITING

MeSH Terms

Conditions

Hypertension, PortalLiver Cirrhosis

Interventions

Conversion to Open SurgeryLaparoscopy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Yang Liu, Doctor

CONTACT

+86-29-87679246individualliu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 30, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

CN(1)