Jalan 1997.
| Methods | Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: adequate. Sealed envelopes in batches of 25.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation: 24 hours after cessation of bleeding. Time from randomisation to treatment in days (mean): TIPS (2.2), VB ie, variceal banding (2.4). Total number of patients evaluated and found eligible: 61 (105 evaluated). Randomised to TIPS: 31, randomised to ET: 27. Adequate reasons provided for those not randomised: yes. Three patiens in the TIPS group did not receive the allocated treatment and six patients in the endoscopic therapy were crossed over to TIPS during follow‐up. No losses to follow‐up. Intention‐to‐treat analysis. Follow‐up period months (mean, SD) TIPS (15.7,10.2) ET (16.8,10.9). Assessment of suitability for shunt carried out prior to randomisation: yes. Shunt patency assessed with duplex scanning and portography at one week, one month and then every six months. Method of Child's grading: Child‐Pugh. Method of encephalopathy testing: Parson‐Smith criteria. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: yes. |
|
| Participants | Inclusion criteria: all cirrhotic patients between 18 and 75 yrs of age who presented with a first (index) episode of variceal bleeding. Exclusions (one or more of the following): rebleeding from varices from varices within 24 hours of initial endoscopy, bleeding from ectopic varices, previous endoscopic treatment for varices, malignancy, portal vein thrombosis. Patients characteristic similar in the two groups. |
|
| Interventions | ET:
Variceal banding ligation, single application. Shunt: TIPS (wall stent). |
|
| Outcomes | Variceal rebleeding. Survival. Encephalopathy. Complications: sepsis, shunt dysfunction. Cost analysis and amount of time spent in‐patient. | |
| Notes | Only trial to employ variceal banding. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |