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Status unknownNCT02178319Updated Jun 30, 2014

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

An interventional study of open surgical procedure and laparoscopic surgical procedure in Portal Hypertension and Liver Cirrhosis, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2014-06-30.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Portal Hypertension
  • Liver Cirrhosis

Keywords

  • portal hypertension
  • Randomized clinical trial
  • laparoscopic
  • open
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 68 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    open group

    the patients under go the open esophagogastric devascularization and splenectomy

    Procedure: open surgical procedure

  • Experimental
    laparoscopic group

    the patients under go the laparoscopic esophagogastric devascularization and splenectomy

    Procedure: laparoscopic surgical procedure

Interventions

  • Procedureopen surgical procedure

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

  • Procedurelaparoscopic surgical procedure

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

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What researchers measure

Primary outcomes

  1. recurrence

    gastroesophageal varices recurrence rate

    Time frame: 5 years

Secondary outcomes

  1. operation time

    Duration of surgical procedure

    Time frame: 1 day

Other outcomes

  1. blood loss during surgical procedure

    Time frame: 1 day

  2. blood transfusion during surgical procedure

    Time frame: 1 day

  3. Number of Participants with Serious and Non-Serious Adverse Events

    record all kind of postoperative complications in each patient

    Time frame: 4 weeks

  4. rebleeding

    record rebleeding time in each bleeding patient

    Time frame: 1 day

  5. cost of hospitalization

    Time frame: 4 weeks

  6. survival

    record the time of death and the death reason

    Time frame: 5 years

  7. length of hospital stay

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
    Xi'an, 710004, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02178319
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jun 30, 2014
Start date
Jun 2014
Primary completion
Jun 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Jun 30, 2014

Study contacts

Yang Liu, Doctor
Contact
individualliu@163.com
+86-29-87679246

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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