NCT00965744

Brief Summary

The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure vessels sealing system) in esophagogastric decongestion and splenectomy in patients with portal hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
Last Updated

August 27, 2009

Status Verified

August 1, 2009

Enrollment Period

2.9 years

First QC Date

August 25, 2009

Last Update Submit

August 26, 2009

Conditions

Liver Cirrhosis

Keywords

Ligasure vessel sealing systemAzygoportal DisconnectionSplenectomyPortal hypertension

Outcome Measures

Primary Outcomes (1)

  • Operating time, from the skin incision to the final skin closure. Intraoperative blood loss, calculated by a graduated suction device and by amounts of blood involved into the sponges by the end of the operation.

    Within the operation

Secondary Outcomes (1)

  • Postoperative drainage volume, complications (spleen fever, bleeding and portal vein thrombosis), length of incision, postoperative pain and time to discharge.

    within the first 30 days after surgery

Study Arms (2)

Vessel sealing system LigaSure (VS group)

EXPERIMENTAL

Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.

Device: Vessel sealing system LigaSure

Conventional hand-tied method (CH group)

NO INTERVENTION

Patients in CH group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the conventional hand-tied method.

Interventions

Vessel sealing system LigaSureDEVICE

Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.

Vessel sealing system LigaSure (VS group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy

You may not qualify if:

  • Liver function as Child-Pugh C
  • Hemoglobin \< 9 g/dL
  • Ascites
  • Abnormal coagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Shanghai Chang Zheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qiang Wang, MD

    Shanghai Chang Zheng Hospital

    STUDY CHAIR

  • Jia Dong Gao, MD

    Department of General Surgery, Shanghai Chang Zheng Hospital

    PRINCIPAL INVESTIGATOR

  • Wei Jun Wang, MD

    Department of General Surgery, Shanghai Chang Zheng Hospital

    PRINCIPAL INVESTIGATOR

  • Hou Shan Yao, MD

    Department of General Surgery, Shanghai Chang Zheng Hospital

    PRINCIPAL INVESTIGATOR

  • Zhi Qian Hu, MD

    Department of General Surgery, Shanghai Chang Zheng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 27, 2009

Record last verified: 2009-08

Locations

CN(1)