Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial
Primary Purpose
Portal Hypertension, Liver Cirrhosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
open surgical procedure
laparoscopic surgical procedure
Sponsored by
About this trial
This is an interventional treatment trial for Portal Hypertension focused on measuring portal hypertension, Randomized clinical trial, laparoscopic, open
Eligibility Criteria
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.
Sites / Locations
- Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
open group
laparoscopic group
Arm Description
the patients under go the open esophagogastric devascularization and splenectomy
the patients under go the laparoscopic esophagogastric devascularization and splenectomy
Outcomes
Primary Outcome Measures
recurrence
gastroesophageal varices recurrence rate
Secondary Outcome Measures
operation time
Duration of surgical procedure
Full Information
NCT ID
NCT02178319
First Posted
June 19, 2014
Last Updated
June 26, 2014
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT02178319
Brief Title
Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial
Official Title
Randomized Clinical Trial Comparing Laparoscopic and Open Esophagogastric Devascularization and Splenectomy for Portal Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Liver Cirrhosis
Keywords
portal hypertension, Randomized clinical trial, laparoscopic, open
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open group
Arm Type
Active Comparator
Arm Description
the patients under go the open esophagogastric devascularization and splenectomy
Arm Title
laparoscopic group
Arm Type
Experimental
Arm Description
the patients under go the laparoscopic esophagogastric devascularization and splenectomy
Intervention Type
Procedure
Intervention Name(s)
open surgical procedure
Intervention Description
open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgical procedure
Intervention Description
laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
Primary Outcome Measure Information:
Title
recurrence
Description
gastroesophageal varices recurrence rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
operation time
Description
Duration of surgical procedure
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
blood loss during surgical procedure
Time Frame
1 day
Title
blood transfusion during surgical procedure
Time Frame
1 day
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
record all kind of postoperative complications in each patient
Time Frame
4 weeks
Title
rebleeding
Description
record rebleeding time in each bleeding patient
Time Frame
1 day
Title
cost of hospitalization
Time Frame
4 weeks
Title
survival
Description
record the time of death and the death reason
Time Frame
5 years
Title
length of hospital stay
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Liu, Doctor
Phone
+86-29-87679246
Email
individualliu@163.com
Facility Information:
Facility Name
Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
City
Xi'an
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Liu, Doctor
Phone
+86-29-87679246
Email
individualliu@163.com
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial
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