search
Back to results

Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection (VNRSD)

Primary Purpose

Cirrhosis, Hypertension, Splenectomy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vagus nerve-guided group
Sponsored by
Guo-Qing Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis focused on measuring Vagus nerve, Delayed gastric emptying, Cirrhosis, Hypertension, Robotic-assisted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Delayed gastric emptying
  2. Diarrhea
  3. Hepatocellular carcinoma or any other malignancy,
  4. Hypercoagulable state other than the liver disease related
  5. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
  6. Child - Pugh C
  7. Recent peptic ulcer disease
  8. History of Hemorrhagic stroke
  9. Pregnancy.
  10. Uncontrolled Hypertension
  11. Human immunodeficiency virus (HIV) infection

Sites / Locations

  • Clinical Medical College, Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

vagus nerve-guided group

Conventional group

Arm Description

Procedure/Surgery: vagus nerve-guided group The vagus nerve-guided procedure was performed in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, blunt dissect the left lateral surface of the distal esophagus using Bipolar Forceps, and find posterior vagal trunk; (3) along posterior vagal trunk towards left lateral esoph-agogastric junction, find and protect gastric and celiac branches; (4) enter the lesser omental sac from the right crural diaphragm using Bipolar Forceps; (5) transect the left gastric artery and vein together using a linear vascular stapler; (6) blunt dissect the anterior surface of the distal esophagus using Bipolar Forceps, and find anterior vagal trunk; (7) along anterior vagal trunk towards right lateral esoph-agogastric junction, find and protect gastric and hepatic branches; and (8) blunt dissect the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved.

Every patient of conventional group will receive the conventional Robotic-assisted azygoportal disconnection procedure.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative complications of the digestive system
Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.
Esophagogastric variceal re-bleeding
Proportions of patients who will suffer from esophagogastric variceal re-bleeding in both groups.

Full Information

First Posted
March 18, 2022
Last Updated
July 23, 2023
Sponsor
Guo-Qing Jiang
search

1. Study Identification

Unique Protocol Identification Number
NCT05300516
Brief Title
Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection
Acronym
VNRSD
Official Title
Vagus Nerve-guided Versus Conventional Robotic-assisted Splenectomy and Azygoportal Disconnection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guo-Qing Jiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aimed to evaluate whether vagus nerve-guided robotic-assisted 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 robotic-assisted splenectomy and azygoportal disconnection.
Detailed Description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-guided robotic-assisted splenectomy and azygoportal disconnection) or control (conventional robotic-assisted splenectomy and azygoportal disconnection) group. From postoperative day 3, all patients will receive 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3 after operation, electron gastroscopy examination for delayed gastric emptying will be done for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at the seventh day and months 3 after operation. Then 3 months monitoring will be done in the both groups as per the primary or secondary outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Hypertension, Splenectomy, Robotic-assisted
Keywords
Vagus nerve, Delayed gastric emptying, Cirrhosis, Hypertension, Robotic-assisted

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vagus nerve-guided group
Arm Type
Experimental
Arm Description
Procedure/Surgery: vagus nerve-guided group The vagus nerve-guided procedure was performed in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, blunt dissect the left lateral surface of the distal esophagus using Bipolar Forceps, and find posterior vagal trunk; (3) along posterior vagal trunk towards left lateral esoph-agogastric junction, find and protect gastric and celiac branches; (4) enter the lesser omental sac from the right crural diaphragm using Bipolar Forceps; (5) transect the left gastric artery and vein together using a linear vascular stapler; (6) blunt dissect the anterior surface of the distal esophagus using Bipolar Forceps, and find anterior vagal trunk; (7) along anterior vagal trunk towards right lateral esoph-agogastric junction, find and protect gastric and hepatic branches; and (8) blunt dissect the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved.
Arm Title
Conventional group
Arm Type
No Intervention
Arm Description
Every patient of conventional group will receive the conventional Robotic-assisted azygoportal disconnection procedure.
Intervention Type
Procedure
Intervention Name(s)
vagus nerve-guided group
Intervention Description
The vagus nerve-guided procedure was performed in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, blunt dissect the left lateral surface of the distal esophagus using Bipolar Forceps, and find posterior vagal trunk; (3) along posterior vagal trunk towards left lateral esoph-agogastric junction, find and protect gastric and celiac branches; (4) enter the lesser omental sac from the right crural diaphragm using Bipolar Forceps; (5) transect the left gastric artery and vein together using a linear vascular stapler; (6) blunt dissect the anterior surface of the distal esophagus using Bipolar Forceps, and find anterior vagal trunk; (7) along anterior vagal trunk towards right lateral esoph-agogastric junction, find and protect gastric and hepatic branches; and (8) blunt dissect the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved.
Primary Outcome Measure Information:
Title
Diarrhea
Description
Proportions of patients who will suffer from diarrhea in both groups.
Time Frame
3 month
Title
Delayed gastric emptying
Description
Proportions of patients who will suffer from delayed gastric emptying in both groups.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Postoperative complications of the digestive system
Description
Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.
Time Frame
3 month
Title
Esophagogastric variceal re-bleeding
Description
Proportions of patients who will suffer from esophagogastric variceal re-bleeding in both groups.
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Human immunodeficiency virus (HIV) infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-Qing Jiang, MD
Phone
+8651487373272
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dou-sheng Bai, MD
Phone
86-514-87373275
Email
bdsno1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dou-Sheng Bai, MD
Organizational Affiliation
Clinical Medical College, Yangzhou University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Organizational Affiliation
Clinical Medical College, Yangzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Chen, MD
Organizational Affiliation
Clinical Medical College, Yangzhou University
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Medical College, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Phone
86-514-87373372
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dou-Sheng Bai, MD
Phone
86-514-87373372
Email
bdsno1@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
First Name & Middle Initial & Last Name & Degree
Tian-Ming Gao, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection

We'll reach out to this number within 24 hrs