Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices

NCT01426087 | Unknown DMC

• 1 other identifier: 0105467801
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. Somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. In the study, the investigators explore the effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices.

Conditions

Esophageal Varices Secondary to Cirrhosis of Liver

Outcome Measures

Primary Outcomes (1)

• Portal vein blood flow volume

  Note: 1. Portal vein blood flow volume will be measured by doppler ultrasound device. 2. Values are the mean of three consecutive measurements. 3. Frequency: PVF will be measured on baseline, day1, day 5 and day 7. 4. All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation.

  change from baseline in portal vein blood flow volume after 7 days treatment

Secondary Outcomes (3)

• Portal vein diameter (PVD mm)

  change from baseline in PDV after 7 days treatment

• Mean portal vein blood velocity (PVV cm/s)

  change from baseline in PVV after 7 days treatment

• Ascites volume

  change from baseline after 7 days treatment

Study Arms (2)

endoscopic and somatostatin treatment

EXPERIMENTAL

Drug: Somatostatin

endoscopic therapy

OTHER

Procedure: endoscopic therapy

Interventions

Somatostatin DRUG

giving stilamin 250ug/h after endoscopic therapy for 5 days

Also known as: stilamin

endoscopic and somatostatin treatment

endoscopic therapy PROCEDURE

gastroscope plus EIS/EVL/HI

Also known as: antisterone,DHCT,albumin or antibiotics

endoscopic therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis with esophageal gastric varices needed endoscopic therapy
• Age 18-75 years
• Informed written consent

You may not qualify if:

• Use of vasoactive drugs 24 hours before endoscopic treatment
• Use of B-blocker within 1 week
• Previous surgical or endoscopic treatment for esophageal gastric varices
• Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy
• Gastro-renal vein shunt
• Severe hepatic hydrothorax
• Hepatocellular carcinoma with portal vein thrombosis
• Severe coagulation disorders
• Severe active bacteria infection
• Severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure
• Severe renal function insufficiency （Calculated Creatinine Clearance Rate (Ccr) \<30ml/min）
• Severe co-morbidity that would affect short-term prognosis
• Pregnancy or lactation
• Allergy to any ingredient of trial medication
• Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent

Sponsors & Collaborators

• Yunsheng Yang: lead

Study Sites (1)

Site

Beijing, 010, China

RECRUITING

MeSH Terms

Interventions

Somatostatin; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yun Sh Yang, Pro.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chinese PLA General Hospital

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

CN (1)