Secondary Prevention of Variceal Rebleeding by Endoscopic Ultrasound-guided Therapy Versus Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients: a Randomized Controlled Trial

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

Rebleeding rate is high in hepatocellular carcinoma (HCC) patients with variceal bleeding despite conventional endoscopic therapies for esophageal and gastric varices (EV, GV). Secondary prevention of variceal rebleeding was reported to improve outcomes of HCC patients, but the optimal endoscopic approach is not well defined. In this difficult-to-manage population, variceal rebleeding rates remain substantial after conventional endoscopic therapies. n recent studies by others and our group on direct EUS-guided therapy for varices in cirrhotic patients, high technical success (90 - 100%), low post-treatment rebleeding rate (3 - 11%) and low adverse event rate (\ 3%) have been reported for GV treatment by cyanoacrylate glue injection, coiling or a combination of both, and for cyanoacrylate glue injection or coiling of EV refractory to variceal band ligation (VBL). This study aims to compare rebleeding rates after secondary prevention by EUS-guided therapy or conventional endoscopic therapy in HCC patients with recent variceal bleeding.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Consecutive HCC patients age 18 or older with recent (within 4 weeks of the episode) EV or GV bleeding successfully controlled by conventional endoscopic therapies (VBL for EV or glue injection for GV)

• Able to provide written informed consent to participate in the study and comply with the study procedures

Locations

Other Locations

Hong Kong Special Administrative Region

Prince of Wales Hospital, The Chinese University of Hong Kong

RECRUITING

Shatin

Contact Information

Primary

Raymond S Tang, MD

raymondtang@cuhk.edu.hk

(852) 26370428

Backup

Felix Sia, BS

felixsia@cuhk.edu.hk

(852) 26370428

Time Frame

Start Date: 2022-11-22

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 84

Treatments

Active_comparator: EUS-guided therapy group

EUS would be performed with a curvilinear echoendoscope based on protocol described in our prior study. Because EUS-guided glue injection can be applied to both EV and GV and is less technically demanding than coiling or the combination approach, it is chosen as the EUS guided intervention in our study. The target EV or GV size will be measured by the caliper function on the EUS machine. After confirmation of blood flow in the target varix by Doppler, EUS-guided glue injection would be performed for EV or GV ≥ 3mm in diameter using a standard 19G needle. Each injection will contain a 1.2ml mixture of 0.5ml glue (Histoacryl, n-butyl-2-cyanoacrylate, B. Braun Surgical, Germany) + 0.7ml lipiodol. Flow obliteration in the treated varix will be confirmed on EUS Doppler. If blood flow is still observed on Doppler after the first injection, additional injection of glue-lipiodol mixture would be repeated (up to 4 doses) until flow obliteration is achieved.

Active_comparator: Conventional endoscopic therapy group

In patients with prior EV bleeding, EV with high-risk stigmata (regardless of size) or EV of medium or large size detected on study EGD will be treated with VBL using a multi-band ligator fitted on the gastroscope for secondary prevention. In patients with prior GV bleeding, if compressible GV suggestive of incomplete obliteration from prior glue treatment is noted on study EGD, cyanoacrylate glue injection using a 1.2ml mixture of 0.5ml glue (Histoacryl, n-butyl-2-cyanoacrylate, B. Braun Surgical, Germany) + 0.7ml lipiodol will be performed for secondary prevention.

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Secondary Prevention of Variceal Rebleeding by Endoscopic Ultrasound-guided Therapy Versus Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients: a Randomized Controlled Trial

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