NCT03396796

Brief Summary

This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional laparoscopic splenectomy and azygoportal disconnection.

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 not_applicable

Timeline
Completed

Started Apr 2018

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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

January 4, 2018

Last Update Submit

January 18, 2020

Conditions

CirrhosisHypertensionSplenectomyLaparoscopy

Keywords

Vagus nerveDelayed gastric emptyingCirrhosisHypertensionlaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Delayed gastric emptying

    Proportions of patients who will suffer from delayed gastric emptying in both groups.

    1 year

Secondary Outcomes (6)

  • Postoperative complications of the digestive system

    1 year

  • Body weight

    1 year

  • Hepatic decompensation

    1 year

  • Portal vein system thrombosis

    1 year

  • Hepatocellular carcinoma

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Vagus nerve-preserving group

EXPERIMENTAL

Every patient of vagus nerve-preserving group will receive the modified vagus nerve-preserving laparoscopic azygoportal disconnection procedure.

Procedure: Vagus nerve-preserving group

Conventional group

NO INTERVENTION

Every patient of conventional group will receive the conventional laparoscopic azygoportal disconnection procedure.

Interventions

Vagus nerve-preserving groupPROCEDURE

The modified vagus nerve-preserving procedure was performed in the following order: (1) left gastroepiploic vein along greater curvature; (2) the posterior surface of stomach, including the posterior gastric veins; (3) the left lateral surface of the distal esophagus; (4) the left inferior phrenic veins; (5) the posterior surface of the distal esophagus;(6) the anterior surface of the distal esophagus; and (7) the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved. the adherent junction between visceral peritoneum and the right crural diaphragm, and divided it into the lesser omental sac. The left gastric artery and vein and the posterior gastric veins were transected en bloc using a linear laparoscopic vascular stapler.

Vagus nerve-preserving group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
  • Splenomegaly with secondary hypersplenism
  • Bleeding portal hypertension
  • No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
  • Informed consent to participate in the study

You may not qualify if:

  • Delayed gastric emptying
  • Diarrhea
  • Hepatocellular carcinoma or any other malignancy,
  • Hypercoagulable state other than the liver disease related
  • DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
  • Child - Pugh C
  • Recent peptic ulcer disease
  • History of Hemorrhagic stroke
  • Pregnancy.
  • Uncontrolled Hypertension
  • Age\>75 yrs
  • Human immunodeficiency virus (HIV) infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

FibrosisHypertensionGastroparesis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Dou-Sheng Bai, MD

    Clinical Medical College of Yangzhou University

    STUDY CHAIR

  • Guo-Qing Jiang, MD

    Clinical Medical College of Yangzhou University

    PRINCIPAL INVESTIGATOR

  • Ping Chen, MD

    Clinical Medical College of Yangzhou University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 11, 2018

Study Start

April 9, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

CN(1)