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Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection

NCT ID: NCT05300516

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Cirrhosis Hypertension Splenectomy Robotic-assisted

Keywords

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Vagus nerve Delayed gastric emptying Cirrhosis Hypertension Robotic-assisted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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vagus nerve-guided group

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.

Group Type EXPERIMENTAL

vagus nerve-guided group

Intervention Type 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.

Conventional group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Jiangsu People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guo-Qing Jiang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dou-Sheng Bai, MD

Role: STUDY_CHAIR

Clinical Medical College, Yangzhou University

Guo-Qing Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Medical College, Yangzhou University

Ping Chen, MD

Role: STUDY_DIRECTOR

Clinical Medical College, Yangzhou University

Locations

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Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36478144 (View on PubMed)

Other Identifiers

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YZUC-008

Identifier Type: -

Identifier Source: org_study_id