title: Randomized controlled trial comparing endoscopic ligation with or without sclerotherapy for secondary prophylaxis of variceal bleeding.
abstract: OBJECTIVE
  A recently published network meta-analysis showed that ligation combined with sclerotherapy might be the most efficacious intervention for secondary prophylaxis of variceal bleeding. Most studies excluded patients with concomitant gastric varices; thus, the outcomes in such patients have not yet been reported. The present study aimed to investigate the efficacy of two endoscopic procedures for secondary prophylaxis in cirrhotic patients presenting with both esophageal and gastric varices.
  
  
  METHODS
  A randomized controlled study was carried out in a tertiary care referral center. Patients were randomized into two groups: sclerotherapy- and sclerotherapy+ group. Continued endoscopic ligation was used to treat esophageal varices in the sclerotherapy- group, whereas combined ligation and sclerotherapy with lauromacrogol was performed in the sclerotherapy+ group. A cyanoacrylate injection was used for gastric varices in both groups. All participants were followed up for 6 months.
  
  
  RESULTS
  Overall, 96 patients were included between 25 March 2012 and 25 June 2013. Three patients were lost during follow-up (one in the sclerotherapy- group and two in the sclerotherapy+ group). The cumulative recurrence rate of bleeding was significantly higher in the sclerotherapy+ group (14.6 vs. 35.4%, P=0.013). The cumulative mortality rate (2.1 vs. 6.3%, P=0.286) and the incidence rate of adverse events were similar between the two groups.
  
  
  CONCLUSIONS
  Continued ligation+cyanoacrylate injection was superior to combined ligation and sclerotherapy+cyanoacrylate injection during the first 6 months in terms of rebleeding in cirrhotic patients presenting with both esophageal and gastric varices. Long-term results entail further investigation (http://www.clinicaltrials.gov, NCT01592578).
authors.affiliation: aDepartment of Gastroenterology bEndoscopy Center and Endoscopy Research Institute cDepartment of Gastroenterology, Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Chen
authors.forename: Xiao-Qing
authors.initials: XQ
authors.lastname: Zeng
authors.forename: Li-Li
authors.initials: LL
authors.lastname: Ma
authors.forename: Bing
authors.initials: B
authors.lastname: Li
authors.forename: Yu-Jen
authors.initials: YJ
authors.lastname: Tseng
authors.forename: Jing-Jing
authors.initials: JJ
authors.lastname: Lian
authors.forename: Hong
authors.initials: H
authors.lastname: Gao
authors.forename: Jian
authors.initials: J
authors.lastname: Wang
authors.forename: Tian-Cheng
authors.initials: TC
authors.lastname: Luo
authors.forename: Shi-Yao
authors.initials: SY
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D003487:Cyanoacrylates / Q000627:therapeutic use; D004932:Esophageal and Gastric Varices / Q000150:complications / Q000628:therapy*; D004945:Esophagoscopy; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D008026:Ligation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012008:Recurrence; D012597:Sclerosing Solutions / Q000627:therapeutic use; D015911:Sclerotherapy / Q000009:adverse effects; D015996:Survival Rate
chemical_list: D003487:Cyanoacrylates; D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols