Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation
Condition: Cirrhosis; Hypertension; Splenectomy; Laparoscopy
MeSH terms: Hypertension; Fibrosis
Study type: Interventional

Summary: 
      This study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic
      splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation
      (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the
      incidence of postoperative esophageal variceal re-bleeding.
    

Detailed description: 
      After successful screening the cases of cirrhosis of liver irrespective of the etiology who
      have prior esophageal/gastroesophageal variceal bleeding will be enrolled. The baseline
      parameter will be recorded and the patient will be randomized into either interventional
      (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection
      with intraoperative endoscopic variceal ligation (SVEL)) or control (single vagus
      nerve-preserving laparoscopic splenectomy and azygoportal disconnection without
      intraoperative endoscopic variceal ligation (SVEL)) 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, 6, and 12 after operation, endoscopic intervention will be
      done for all patients. Endoscopic variceal ligation was made if the diameter of the
      esophageal varices was >5 mm. Postoperative complications of esophageal variceal re-bleeding
      and death due to re-bleeding will be recorded during the postoperative first year monitoring
      in the both groups as per the primary or secondary outcome.
    

Intervention name(s): laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation
Intervention type(s): Procedure
Intervention description(s): The modified procedure was implemented in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, divide the left lateral surface of the distal esophagus; (3) divide the posterior surface of the distal esophagus; (4) divide the anterior surface of the distal esophagus; (5) divide the lesser omental sac via the bottom right crural diaphragm; (6) transect en bloc the left gastric artery and vein and posterior gastric veins using a linear laparoscopic vascular stapler; (7) find the right crural diaphragm by dividing a small portion of the hepatogastric ligament at the left lateral esophagogastric junction; and (8) via the surface of the right crural diaphragm, divide the right lateral surface of the distal esophagus.
After the procedure of laparoscopic azygoportal disconnection, intraoperative endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vagus nerve; Esophageal variceal re-bleeding; Cirrhosis; Hypertension; laparoscopy