Sarin 2002.
Methods | N‐butyl‐2‐cyanoacrylate vs. absolute alcohol for active or recent bleeding from isolated (IGV1 or GOV2) gastric varices. 1995 to 1998. Generation of allocation sequence: table of random numbers; concealment of allocation sequence: not described. Blinding: participants and personnel not blinded. Intention‐to‐treat: no. Interim analysis: none. Follow‐up period: 14 months. |
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Participants | India. Single‐centre randomised clinical trial. 37 participants, 17 in alcohol group, 20 in cyanoacrylate group. Active or acute bleeding from IGV1 or GOV2 only gastric varices probed by endoscopy. Portal hypertension. Treatment made after admission. Similar demographics and clinical characteristics in both groups. Same general treatment: vasoactive drugs (somatostatin or octreotide 48 to 120 hours after admission). |
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Interventions | Experimental: cyanoacrylate 0.5 mL plus lipiodol 0.7 mL. 21‐gauge needle. 1.2 to 4.6 mL. Control: absolute alcohol group. 21‐gauge needle. 2 to 9 paravariceal injections and 1 to 3 intravariceal. 0.5 to 1.0 mL each. Concomitant oesophageal varices: only isolated varices were treated. Oesophageal was non‐existent or small. There was no treatment for them. Number of sessions to eradicate (mean ± SD): cyanoacrylate: 2.0 ± 1.6. Alcohol: 4.7 ± 3.2. Follow‐up endoscopy: every week until obliteration. Follow‐up post‐obliteration: every 3 to 6 weeks. Treatment for re‐bleeding: emergency endoscopy, same method. 2 failures: emergency rescue surgery. |
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Outcomes | Control active bleeding. Variceal obliteration. Re‐bleeding. Mortality. Failure of treatment. Complications. |
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Notes | Mixed acute and past bleeding. Only isolated varix was chosen (GOV2 and IGV1 were considered Isolated varices). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers after initial endoscopy "Patients were randomised using a table of random numbers immediately at the time of the initial endoscopy", pp 1011. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were not blinded. Methods of blinding personnel were not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No losses of follow‐up are described. No intention‐to‐treat. |
Selective reporting (reporting bias) | Low risk | All primary (success controlling bleeding,obliteration and re‐bleeding) and secondary (time for obliteration, recurrence and bleeding related mortality) outcomes were described. Description of outcomes in methods match up to those in results, pp 1012, tables 1 and 3, pp 1012 to 1013. |
Other bias | Unclear risk | Only isolated varix. Mixed acute and past bleeding. |