Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/02/2006
Date assigned
30/03/2006
Last edited
29/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gin-Ho Lo

ORCID ID

Contact details

386 Ta-Chung 1st Road
Kaohsiung
813
Taiwan
+886 (0)7 3422121/2075
ghlo@isca.vghks.gov.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NSC 94-2314-B-075B-010

Study information

Scientific title

Acronym

Study hypothesis

The majority of patients with acute oesophageal variceal bleeding stop bleeding during endoscopy. It is still unknown whether endoscopic therapy is beneficial in those patients with acute inactive oesophageal variceal bleeding.

Ethics approval

Approved by the Veterans General Hospital Kaohsiung (VGHKS), reference number: 94-CT1-01

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute oesophageal variceal bleeding but stopped bleeding during emergency endoscopy

Intervention

Group 1: terlipressin infusion for five days
Group 2: banding ligation performed during emergency endoscopy and terlipressin infusion for two days

Intervention type

Drug

Phase

Not Specified

Drug names

Terlipressin

Primary outcome measures

Initial control of variceal bleeding after 48 hours of treatment

Secondary outcome measures

Early rebleeding between 48-120 hours after treatment

Overall trial start date

01/01/2005

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cirrhotic patients
2. Acute oesophageal variceal bleeding proven by emergency endoscopy within 12 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Association with advanced hepatocellular carcinoma (HCC)
2. Association with other severe systemic illness
3. Association with gastric variceal bleeding
4. Previous shunt operation, endoscopic variceal ligation (EVL), beta-blocker or isosorbide mononitrate (ISMN) within one month
5. Serum bilirubin >10 mg/dl, creatinine >3 mg/dl
6. Presence of encephalopathy >grade 2
6. History of coronary artery disease
7. Uncooperative

Recruitment start date

01/01/2005

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Taiwan

Trial participating centre

386 Ta-Chung 1st Road
Kaohsiung
813
Taiwan

Sponsor information

Organisation

Republic of China National Science Council (Taiwan)

Sponsor details

106 Ho-Ping East Road
Section 2
Taipei
106
Taiwan
+886 (0)2 27377541
pihsu@vghks.gov.tw

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Republic of China National Science Council (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19386609

Publication citations

  1. Results

    Lo GH, Chen WC, Wang HM, Lin CK, Chan HH, Tsai WL, Cheng LC, Yu HC, Tsay FW, Low-dose terlipressin plus banding ligation versus low-dose terlipressin alone in the prevention of very early rebleeding of oesophageal varices., Gut, 2009, 58, 9, 1275-1280, doi: 10.1136/gut.2008.165910.

Additional files

Editorial Notes