Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices

NCT00820781 | Completed DMC

• 1 other identifier: ESTVPCSBGV
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

Brief Summary

In unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.

Conditions

Gastric Bleeding; Cirrhosis

Keywords

bleeding gastric varices; cirrhosis of the liver; portacaval shunt; endoscopic variceal sclerotherapy; endoscopic variceal ligation; Bleeding gastric varices due to cirrhosis of the liver

Outcome Measures

Primary Outcomes (1)

• Survival

  10 years

Secondary Outcomes (1)

• Control of bleeding and quality of life

  10 years

Study Arms (2)

Portacaval shunt

ACTIVE COMPARATOR

Undergo portacaval shunt surgery

Procedure: Portacaval shunt

Sclerotherapy

ACTIVE COMPARATOR

Undergo endoscopic sclerotherapy

Procedure: Sclerotherapy

Interventions

Portacaval shunt PROCEDURE

Subject taken to the operating room and undergoes portacaval shunt surgery

Portacaval shunt

Sclerotherapy PROCEDURE

Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy

Sclerotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ("all comers").

You may not qualify if:

• None

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103-8999, United States

Location

Related Publications (1)

• Orloff MJ, Hye RJ, Wheeler HO, Isenberg JI, Haynes KS, Vaida F, Girard B, Orloff KJ. Randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic shunt versus portacaval shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis. Surgery. 2015 Jun;157(6):1028-45. doi: 10.1016/j.surg.2014.12.003.

  PMID: 25957003 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Portacaval Shunt, Surgical; Sclerotherapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Drug Therapy; Therapeutics

Study Officials

• Marshall J Orloff, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: August 1, 1977
• Primary Completion: December 1, 1977
• Study Completion: April 1, 2003
• Last Updated: January 12, 2009

Record last verified: 2008-12

Locations

US (1)