Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection (ESVLSD)
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|ClinicalTrials.gov Identifier: NCT03396796|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis Hypertension Splenectomy Laparoscopy||Procedure: Vagus nerve-preserving group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection|
|Actual Study Start Date :||April 9, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
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.
- Delayed gastric emptying [ Time Frame: 1 year ]Proportions of patients who will suffer from delayed gastric emptying in both groups.
- Postoperative complications of the digestive system [ Time Frame: 1 year ]Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.
- Body weight [ Time Frame: 1 year ]Proportions of patients who will show improvement in body weight both groups.
- Hepatic decompensation [ Time Frame: 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 [ Time Frame: 1 year ]Proportions of patients who will suffer from portal vein system thrombosis in both groups.
- Hepatocellular carcinoma [ Time Frame: 1 year ]Proportions of patients who will suffer from hepatocellular carcinoma in both groups.
- Overall survival [ Time Frame: 1 year ]Overall survival in both groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396796
|Contact: Guo-Qing Jiang, MDfirstname.lastname@example.org|
|Contact: Dou-sheng Bai, MDemail@example.com|
|Clinical Medical College of Yangzhou University||Recruiting|
|Yangzhou, Jiangsu, China, 225001|
|Contact: Guo-Qing Jiang, MS 86-514-87373372 firstname.lastname@example.org|
|Contact: Dou-Sheng Bai, MD 86-514-87373375 email@example.com|
|Principal Investigator: Guo-Qing Jiang, MD|
|Sub-Investigator: Sheng-Jie Jin, MD|
|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|