Skip to main content
OpenTrials
Completed

NCT Number: NCT04828369

Efficacy and Safety of EUS-Guided Therapy Versus BRTO for Gastric Varices With Shunt

This study is a retrospective, multi-center and observational clinical study. Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The fifth medical center of PLA General Hospital, Zhongshan Hospital, Fudan University, Shanghai, Nanjing Drum Tower Hospital affiliated Nanjing University Medical School and Xiangyang Central Hospital will participate in the study. Investigators would like to provide evidence-based medical evidence by evaluating and comparing the efficacy and safety of endoscopic ultrasound (EUS)-guided coil embolization combined with endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous obliteration (BRTO) in the treatment of gastric varices (GV) with spontaneous portosystemic shunt (SPSS).

Between January 2014 and December 2020, patients with GV secondary to portal hypertension admitted to a tertiary medical center, are enrolled consecutively according to the following criteria: (1) age≥18 years; (2)endoscopic examination confirms the presence of GV; (3) CTA of the portal system and EUS revealed the presence of SPSS, the diameter was between 5 mm to 15 mm; (4) treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO. Exclusion criteria are as follows: (1)malignant tumors; (2) hepatic encephalopathy, hepatorenal syndrome or multiple organ failure; (3) previously received esophagus or stomach surgery; (4) pregnant.

Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until the progress of the disease or the end of the study. And rebleeding, ectopic embolism, survival, and sequential treatment will be recorded during the follow-up period.

The primary endpoint are five-day rebleeding rate and six-week mortality rate. The secondary endpoint are: technical success rate, incidence of ectopic embolism, eradication of GV, one-year rebleeding rate, one-year mortality rate, and cost-effectiveness ratio. All data and information use SPSS statistical software to complete all statistical analysis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Portal Hypertension Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastric Varix Gastrointestinal Diseases Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portosystemic Shunt

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mingkai Chen

Wuhan, Hubei, 430060, China

About this study

Because the efficacy and safety of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection and BRTO in the treatment of GV with SPSS have different conclusions in different studies. Investigators based on that the five-day rebleeding rate of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection is 7%, BRTO is 10%. The number of people in the two groups are equal, significant level (α) is 0.05, and the test power is 0.8. Each group requires 35 patients. Because of the 10% loss to follow-up, the sample capacity is 39.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age≥18 years
  • endoscopic examination confirmed the presence of gastric varices
  • CTA of the portal system and EUS revealed the presence of spontaneous portosystemic shunt (SPSS) that the diameter was between 5 mm to 15 mm
  • treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO

Exclusion criteria

  • malignant tumors
  • hepatic encephalopathy, hepatorenal syndrome or multiple organ failure
  • previously received esophagus or stomach surgery
  • pregnant

Treatment and study plan

EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

Procedure

(1) Standard diagnostic endoscopy was first performed. Fundal varices were assessed using the classification of Sarin's. (2) intraluminal water filling of the gastric fundus to use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. (3) Punctured the gastric fundal variceal vein at the lower esophagus near the cardia and placed the coil into the shunt and immediately injected with sclerosant and cyanoacrylate under the guidance of EUS. (4) Sclerosant and cyanoacrylate were injected into the gastric fundal varices by a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. (5) After the injection, use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.

balloon-occluded retrograde transvenous obliteration

Procedure

(1)A balloon occlusive catheter was inserted into the shunt via the right femoral vein. (2)Investigators performed angiography to evaluate the size and location of GV and the shunt during balloon occlusion. Shunt was occluded by Fogarty balloon. The diameter of the balloon was chosen according to the diameter of shunt. (3)Then investigators injected sclerosant into the portosystemic shunt. (4)Finally, the balloon left in place for 24 hours was gradually deflated when complete occlusion of blood flow of the target shunt was achieved.

Primary outcomes

  1. five-day rebleeding rate

    Time frame: 5 days after treatment

    Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible.

  2. six-week mortality rate

    Time frame: 6 weeks after treatment

    Patients died in six weeks after treatment due to all causes.

Secondary outcomes

  1. technical success rate

    Time frame: in the procedure of treatment

    The coil or balloon was successfully employed and occluded the shunt

  2. incidence of ectopic embolism

    Time frame: up to 3 years after treatment

    Patients occurred ectopic embolism after treatment confirmed by CTA, ultrasound, etc, with or without clinical manifestation

  3. eradication of gastric varices

    Time frame: 1 year after treatment

    Eradication of the gastric varices is defined as absence of gastric varices on endoscopy or absence of blood flow of gastric varices on endoscopic ultrasound

  4. one-year rebleeding rate

    Time frame: 1 year after treatment

    Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible

  5. one-year mortality rate

    Time frame: 1 year after treatment

    Patients died in one year after treatment due to all causes.

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

Efficacy and Safety of EUS-Guided Coil Embolization Combined With Endoscopic Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration for Gastric Varices With High-risk Ectopic Embolism

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2021
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.