Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection

NCT05300516 | Completed DMC

• 1 other identifier: YZUC-008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hypertension; Splenectomy; Robotic-assisted

Keywords

Vagus nerve; Delayed gastric emptying; Cirrhosis; Hypertension; Robotic-assisted

Outcome Measures

Primary Outcomes (2)

• Diarrhea

  Proportions of patients who will suffer from diarrhea in both groups.

  3 month

• Delayed gastric emptying

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

  3 month

Secondary Outcomes (2)

• Postoperative complications of the digestive system

  3 month

• Esophagogastric variceal re-bleeding

  3 month

Study Arms (2)

vagus nerve-guided group

EXPERIMENTAL

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.

Procedure: vagus nerve-guided group

Conventional group

NO INTERVENTION

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

Interventions

vagus nerve-guided group PROCEDURE

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.

vagus nerve-guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

Related Publications (1)

• Bai DS, Jin SJ, Zhou BH, Xiang XX, Qian JJ, Zhang C, Gao TM, Jiang GQ. Vagus nerve-guided (modified Bai-Jiang-style) robotic-assisted laparoscopic splenectomy and azygoportal disconnection. Int J Med Robot. 2023 Apr;19(2):e2490. doi: 10.1002/rcs.2490. Epub 2022 Dec 11.

  PMID: 36478144 DERIVED

MeSH Terms

Conditions

Fibrosis; Hypertension; Gastroparesis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dou-Sheng Bai, MD

  Clinical Medical College, Yangzhou University

  STUDY CHAIR

• Guo-Qing Jiang, MD

  Clinical Medical College, Yangzhou University

  PRINCIPAL INVESTIGATOR

• Ping Chen, MD

  Clinical Medical College, 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: March 18, 2022
• First Posted: March 29, 2022
• Study Start: April 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)