ESVLSD: Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection

Sponsor

Yangzhou University (Other)

Overall Status

Completed

CT.gov ID

NCT03396796

Collaborator

(none)

Enrollment

Location

Arms

20.7

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Hypertension Splenectomy Laparoscopy	Procedure: Vagus nerve-preserving group	N/A

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-preserving laparoscopic splenectomy and azygoportal disconnection) or control (conventional laparoscopic splenectomy and azygoportal disconnection) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, 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, 9, and 12 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, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection

Actual Study Start Date :

Apr 9, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vagus nerve-preserving group Every patient of vagus nerve-preserving group will receive the modified vagus nerve-preserving laparoscopic azygoportal disconnection procedure.	Procedure: Vagus nerve-preserving group 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.
No Intervention: Conventional group Every patient of conventional group will receive the conventional laparoscopic azygoportal disconnection procedure.

Arm

Intervention/Treatment

Experimental: Vagus nerve-preserving group

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

Procedure: Vagus nerve-preserving group

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.

No Intervention: Conventional group

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

Outcome Measures

Primary Outcome Measures

Delayed gastric emptying [1 year]
Proportions of patients who will suffer from delayed gastric emptying in both groups.

Secondary Outcome Measures

Postoperative complications of the digestive system [1 year]
Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.
Body weight [1 year]
Proportions of patients who will show improvement in body weight both groups.
Hepatic decompensation [1 year]
Proportions of patients who will suffer from hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection.
Portal vein system thrombosis [1 year]
Proportions of patients who will suffer from portal vein system thrombosis in both groups.
Hepatocellular carcinoma [1 year]
Proportions of patients who will suffer from hepatocellular carcinoma in both groups.
Overall survival [1 year]
Overall survival in both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Age>75 yrs
Human immunodeficiency virus (HIV) infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Medical College of Yangzhou University	Yangzhou	Jiangsu	China	225001

Sponsors and Collaborators

Yangzhou University

Investigators

Study Chair: Dou-Sheng Bai, MD, Clinical Medical College of Yangzhou University
Principal Investigator: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
Study Director: Ping Chen, MD, Clinical Medical College of Yangzhou University