The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01592578 |
Recruitment Status : Unknown
Verified May 2012 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted : May 7, 2012
Last Update Posted : April 29, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Varice | Procedure: Ligation and Cyanoacrylate Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | August 2013 |
Estimated Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ligation and Cyanoacrylate Group |
Procedure: Ligation and Cyanoacrylate
Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary. |
Experimental: Ligation plus Sclerotherapy and Cyanoacrylate Group |
Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary |
- recurrence rate of variceal hemorrhage [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]recurrence rate of variceal hemorrhage
- eradication rate of the gastroesophageal varices [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months. ]We intend to set eradication rate of the gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
- recurrence rate of the gastroesophageal varices [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months. ]We intend to set recurrence rate of gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
- mortality rate during the follow-up period [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]mortality rate during the follow-up period
- incidence rate of complications associated with endoscopic treatments [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]We intend to set incidence rate of complications associated with endoscopic treatments,to be specific,which include trasient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain. Participants will be followed for up to 6 months starting from the date of randomization.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 72 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with portal hypertension caused by liver cirrhosis who presented with an acute or recent episode of gastroesophageal variceal bleeding and have previously received endoscopic treatments of ligation and cyanoacrylate. Diagnosis of liver cirrhosis or mixed cirrhosis was based on results of liver biopsy or biochemical tests and liver imaging by ultrasonography.
- The extent of the varices range from Moderate to Severe.
- The age of the patients range from 18 to 72 years old.
Exclusion Criteria:
- Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
- Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
- Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
- Patients who have previously received shunt or devascularization operation,TIPS.
- Patients who had portosystemic shunt according to the results of CT scan.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592578
China, Shanghai | |
180 Fenglin Road | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Jie Chen, doctor 86-13764633539 Angelin8716@yahoo.com.cn , 0556289@fudan.edu.cn | |
Principal Investigator: Shiyao Chen, Professor | |
Sub-Investigator: Jie Chen, doctor |
Study Director: | Shiyao Chen, professor | Shanghai Zhongshan Hospital |
Responsible Party: | Shiyao Chen, department of Gastroenterology, Shanghai Zhongshan Hospital |
ClinicalTrials.gov Identifier: | NCT01592578 |
Other Study ID Numbers: |
CSY-CJ-2012 |
First Posted: | May 7, 2012 Key Record Dates |
Last Update Posted: | April 29, 2013 |
Last Verified: | May 2012 |
gastroesophgeal variceal bleeding liver cirrhosis portal hypertension |
Liver Cirrhosis Liver Diseases Digestive System Diseases |