Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Oct 16, 2020; 12(10): 365-377
Published online Oct 16, 2020. doi: 10.4253/wjge.v12.i10.365
Defining the advantages and exposing the limitations of endoscopic variceal ligation in controlling acute bleeding and achieving complete variceal eradication
Jake Krige, Eduard Jonas, Urda Kotze, Christo Kloppers, Karan Gandhi, Hisham Allam, Marc Bernon, Sean Burmeister, Mashiko Setshedi
Jake Krige, Eduard Jonas, Urda Kotze, Christo Kloppers, Karan Gandhi, Hisham Allam, Marc Bernon, Sean Burmeister, Mashiko Setshedi, Departments of Surgery and Medicine, University of Cape Town Health Sciences Faculty, Cape Town 7925, South Africa
Jake Krige, Department of Surgery, University of Cape Town Health Sciences Faculty, Cape Town 7925, South Africa
Author contributions: Krige J, Jonas E and Kotze U devised the study concept and design; Krige J, Kotze U were involved in acquisition of data; Krige J, Jonas E, Kotze U, Kloppers C, Gandhi K, Allam H, Bernon M and Burmeister S analyzed and interpreted the data; Krige J, Jonas E and Kotze U drafted the manuscript; Krige J, Jonas E, Kotze U, Kloppers C, Gandhi K, Allam H, Bernon M, Burmeister S and Setshedi M critically revised the manuscript for important intellectual content; Krige J, Kotze U and Setshedi M carried out the statistical analysis; Krige J and Jonas E provided final approval of the article.
Institutional review board statement: This study was approved by the Human Research Ethics Committee University of Cape Town Health Sciences Faculty.
Conflict-of-interest statement: They authors declare they have no conflict-of-interest.
Data sharing statement: No additional data.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Jake Krige, MBChB, MSc, PhD, FACS, FRCS (Ed), FCS (SA), Emeritus Professor, Department of Surgery, University of Cape Town Health Sciences Faculty, Anzio Road, Cape Town 7925, South Africa. jej.krige@uct.ac.za
Received: April 28, 2020
Peer-review started: April 28, 2020
First decision: May 24, 2020
Revised: June 29, 2020
Accepted: September 11, 2020
Article in press: September 11, 2020
Published online: October 16, 2020
Research background

Bleeding esophageal varices (BEV) is a potentially life-threatening complication in patients with portal hypertension with mortality rates as high as 25% within six weeks of the index variceal bleed. Although endoscopic intervention provides the optimal emergency method to control actively BEV, the risks of bleeding complications remain substantial and as many as 23% of patients have treatment failure within 5-d due to either uncontrolled or early rebleeding. Approximately 60% of survivors rebleed within two years after the initial bleeding episode with a mortality rate of 30%. Secondary prophylaxis to prevent further variceal bleeding is thus crucial.

Research motivation

Endoscopic variceal ligation (EVL) has replaced injection sclerotherapy (IST) as the endoscopic interventional procedure of choice for BEV, supported by randomized controlled trial data that show more rapid eradication of varices with lower rates of recurrent bleeding and fewer endoscopic-related complications. However, few studies have specifically evaluated detailed outcomes in relation to the inherent technical constraints of ligating device design which may influence the effectiveness of EVL in controlling acute variceal bleeding and in particular, achieving complete eradication of varices, a problem conceptually more relevant to endoscopic banding than sclerotherapy.

Research objectives

This analysis, based on a protocol-driven standardized EVL technique from a high-volume academic endoscopy referral center, used STROBE guidelines to assess the efficacy of EVL in controlling acute variceal bleeding, preventing early rebleeding and achieving complete and durable variceal eradication to prevent late recurrent bleeding in a cohort of patients who presented with an index variceal bleeding event.

Research methods

Consecutive adult patients with endoscopically proven BEV between January 2000 and December 2018 were assessed. The outcome of all endoscopic treatments, both emergency and subsequent elective therapy, was analyzed to assess the efficacy of EVL in acute variceal bleeding control and achieving complete and lasting variceal eradication. Data collected included demographic and clinical information, cause of portal hypertension, Child–Pugh score, hematology and liver function tests, liver biopsy, imaging results, endoscopy information, including variceal size, number of bands placed at each session, the interval between and the number of banding sessions. Outcome data included the efficacy of EVL in controlling the acute index bleed, preventing early rebleeding, achieving complete variceal eradication, minimizing late recurrent bleeding and overall survival. The primary endpoints of the study were (1) effective endoscopic control of the index variceal bleeding event and (2) success in achieving complete variceal eradication as defined in the analysis criteria. Secondary endpoints included (1) early rebleeding; (2) variceal recurrence and rebleeding and (3) overall survival.

Research results

Acute control of active variceal bleeding in the 140 patients was highly successful and hemostasis was achieved in 95.7% of patients with minimal banding morbidity. However, varices were completely eradicated in only 45% of patients who survived more than 3 months. Furthermore, varices recurred in 62% of patients previously eradicated and 9.7% of these had further variceal bleeding. Overall, 81% of patients in this study had bleeding that was effectively controlled during the index banding procedure and, after repeat banding, never bled again from esophageal varices. However, the remaining 19% of the cohort had refractory and complicated variceal bleeding and required either balloon tamponade during the index endoscopy (4%) or rebled during the initial hospitalization (3%) or rebled subsequently (12%) over the next 24 months from residual or recurrent esophageal varices.

Research conclusions

In conclusion, this study confirms that EVL provides the optimal endoscopic method both for control of acute bleeding and for the long-term treatment of varices despite the higher tendency for recurrence. Consistent with previous reports EVL in this study was safe with low procedure-related complication rates. While complete visual eradication of varices is more frequently achievable with IST and has consistently been used as the desired endpoint for endoscopic variceal intervention, this goal is not always attainable in EVL.

Research perspectives

In this study we have identified a subgroup of patients with small varices where size and mucosal scarring preclude further safe banding. Importantly we have shown that these patients have “stable varices” with no rebleeding or progression which resulted in “functional eradication” despite the presence of residual small visible varices. The results of this study should stimulate further research to optimize robust and objective endpoints for reporting of EVL which are likely to differ from the historical outcomes reported in previous randomized controlled trials. The elusive Holy Grail of endoscopic variceal banding remains the attainment of long-term bleed-free survival.