Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding

NCT06013670 | Recruiting DMC

• 1 other identifier: 2022-LCYS-MS-13
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of endoscopic therapy combined with non-selective therapy β Receptor blockers (NSBBs) and TIPS in the treatment of liver cirrhosis The impact of reducing bleeding on the survival of critically ill patients. To compare the effect of endoscopic therapy combined with NSBBs drugs and TIPS on rebleeding and incidence of Hepatic encephalopathy in patients with moderate risk of liver cirrhosis hemorrhage.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (2)

• Rebleeding

  Refer to Baveno VII standard for definition of rebleeding.

  24 months

• Hepatic encephalopathy

  The definition and grading of HE refer to the consensus opinion on the diagnosis and treatment of Hepatic encephalopathy in China in 2013. The observation indicators include dominant HE and MHE (OHE). The evaluation of HE is based on the West Haven grading standard. Spontaneous HE is defined as explicit HE that occurs at least once without a clear cause.

  24 months

Study Arms (2)

Endoscopy+NSBBs treatment group

EXPERIMENTAL

Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure\>90mmHg and heart rate\>55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.

Procedure: Endoscopy+NSBBs

TIPS treatment group

EXPERIMENTAL

Patients receives TIPS for the prevention of variceal bleeding

Procedure: Transjugular intrahepatic portosystemic shunt

Interventions

Endoscopy+NSBBs PROCEDURE

Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure\>90mmHg and heart rate\>55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.

Endoscopy+NSBBs treatment group

Transjugular intrahepatic portosystemic shunt PROCEDURE

TIPS group: All TIPS procedures are completed by a professional liver disease intervention treatment team.

TIPS treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed as liver cirrhosis (based on clinical, laboratory examination, imaging, or liver biopsy), and the disease is caused by viral hepatitis cirrhosis or alcoholic cirrhosis.
• mmHg ≤ HVPG ≤ 20mmHg
• Gastroscopy confirms moderate to severe esophageal and gastric varices (EV and GOV1 types) with at least one history of EGVB
• Age 18-80 years old and liver function CTP grading B or C\<14 points
• Sign the informed consent form;
• Expected survival time greater than 1 year

You may not qualify if:

• Patients with cirrhosis associated with non viral hepatitis or Alcoholic hepatitis Taking NSBBs or other medications to treat portal hypertension within the past 6 weeks
• Contraindication for the use of NSBBs, such as bronchial asthma, Cardiogenic shock, heart block (Ⅱ - Ⅲ degree atrioventricular block), severe or acute heart failure and sinus bradycardia
• Simultaneously taking drugs that affect the metabolism and absorption of NSBBs in the body
• TIPS recanalization treatment due to shunt failure
• Serum total bilirubin\>85.5 µ mol/L
• Preoperative evaluation reveals the presence of liver cancer or extrahepatic tumors, severe organ dysfunction, and other factors that affect expected survival disease
• Intractable ascites or hepatorenal syndrome
• Concomitant portal vein cavernous degeneration or severe portal vein system thrombosis
• Women who plan to become pregnant or are already pregnant or breastfeeding

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Feng Zhang

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

• Yuzheng Zhuge

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Feng Zhang

CONTACT

13951872835; fzdndx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 28, 2023
• Study Start: January 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)