Endoscopy 2020; 52(07): 548-555
DOI: 10.1055/a-1127-3170
Original article

A prospective, randomized trial of thrombin versus cyanoacrylate injection in the control of acute gastric variceal hemorrhage

Gin-Ho Lo
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
3   School of Medicine for International Students, I-Shou University, Kaohsiung, Taiwan
,
Chih-Wen Lin
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
2   Division of Gastroenterology, E-DA Hospital, Da-Chung Branch, Kaohsiung, Taiwan
3   School of Medicine for International Students, I-Shou University, Kaohsiung, Taiwan
,
Chi-Ming Tai
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
2   Division of Gastroenterology, E-DA Hospital, Da-Chung Branch, Kaohsiung, Taiwan
,
Daw-Shyong Perng
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
2   Division of Gastroenterology, E-DA Hospital, Da-Chung Branch, Kaohsiung, Taiwan
,
I-Lin Chen
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
,
Jen-Hao Yeh
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
2   Division of Gastroenterology, E-DA Hospital, Da-Chung Branch, Kaohsiung, Taiwan
3   School of Medicine for International Students, I-Shou University, Kaohsiung, Taiwan
,
Hui-Chen Lin
1   Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan
› Author Affiliations
Acknowledgements: The study was sponsored by a grant from E-DA Hospital (EDPJ 99019).

TRIAL REGISTRATION: Single-Center, randomized, prospective trial NCT01717612 at clinicaltrials.gov


Abstract

Background Acute gastric variceal hemorrhage (AGVH) is a serious complication of portal hypertension. Endoscopic cyanoacrylate glue injection is standard therapy for acute hemostasis; however, it may be associated with serious complications. The role of thrombin injection has not been confirmed. This study compared endoscopic thrombin and glue injections in the hemostasis of AGVH.

Methods 68 eligible patients with AGVH were randomized to receive thrombin injection (33 patients) or glue injection (35 patients). The primary end point was injection-induced gastric ulcers. Secondary end points were acute hemostasis, rebleeding, and mortality within 42 days.

Results Both groups had comparable baseline data. Hemostasis of active bleeding at endoscopy was 90.0 % (9/10) in the thrombin group and 90.9 % (10/11) in the glue group (P = 0.58), and 48-hour hemostasis was achieved in 93.9 % (31/33) and 97.1 % (34/35), respectively (P = 0.60). Treatment failure at 5 days occurred in two patients (6.1 %) in the thrombin group and two patients (5.7 %) in the glue group (P > 0.99). Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group (P < 0.001, 95 % confidence interval [CI] 8 % – 27 %). Complications occurred in 4 (12.1 %) and 18 (51.4 %) patients in the thrombin and glue groups, respectively (P < 0.001, 95 %CI 22 % – 45 %). Two patients who received glue had post-treatment gastric ulcer bleeding. One patient in each group died.

Conclusions Endoscopic thrombin injection was similar to glue injection in achieving successful hemostasis of AGVH. However, a higher incidence of complications may be associated with glue injection.



Publication History

Received: 29 August 2019

Accepted: 10 February 2020

Article published online:
14 April 2020

© Georg Thieme Verlag KG
Stuttgart · New York

 
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