A controlled trial of terlipressin plus banding ligation versus terlipressin alone in the management of acute esophageal variceal bleeding
| ISRCTN | ISRCTN28353453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28353453 |
| Protocol serial number | NSC 94-2314-B-075B-010 |
| Sponsor | Republic of China National Science Council (Taiwan) |
| Funder | Republic of China National Science Council (Taiwan) |
- Submission date
- 18/02/2006
- Registration date
- 30/03/2006
- Last edited
- 29/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gin-Ho Lo
Scientific
Scientific
386 Ta-Chung 1st Road
Kaohsiung
813
Taiwan
| Phone | +886 (0)7 3422121/2075 |
|---|---|
| ghlo@isca.vghks.gov.tw |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Approved by the Veterans General Hospital Kaohsiung (VGHKS), reference number: 94-CT1-01 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Terlipressin |
| Primary outcome measure(s) |
Initial control of variceal bleeding after 48 hours of treatment |
| Key secondary outcome measure(s) |
Early rebleeding between 48-120 hours after treatment |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Cirrhotic patients 2. Acute oesophageal variceal bleeding proven by emergency endoscopy within 12 hours |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
386 Ta-Chung 1st Road
Kaohsiung
813
Taiwan
813
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No |
