|Orthotopic liver transplantation: T-tube or not T-tube? Systematic review and meta-analysis of results
|Sotiropoulos GC, Sgourakis G, Radtke A, Molmenti EP, Goumas K, Mylona S, Fouzas I, Karaliotas C, Lang H
This review discouraged biliary T-tube use in duct-to-duct anastomoses in orthotopic liver transplantation since it did not prevent further interventions and was associated with more cholangitis and peritonitis episodes. However, T-tube use was associated with fewer anastomotic and non-anastomotic strictures. The reliability of the authors’ conclusions is not clear due to uncertainties about the quality of included studies.
To compare outcomes after duct-to-duct anastomoses with or without biliary T-tube in orthotopic liver transplantation.
PubMed, EMBASE, the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Library and Scopus were searched from 1990 to 2007 for publications in English. Search terms were reported. Abstracts of meetings of the American Association for the Study of the Liver, the European Association for the Study of the Liver, the Asian Pacific Association for the Study of the Liver, and the Transplantation Library were handsearched. Reviews and commentaries were excluded.
Randomised controlled trials (RCTs) and comparative studies addressing choledocho-choledochal anastomoses in orthotopic liver transplantation, with or without biliary T-tube (as described in the review) were eligible for inclusion. Included studies had to be in adults (of 18 or more years) and have a minimum follow-up of three months. Studies comparing end-to-end versus side-to-side choledocho-choledochostomy, with Roux-en-Y hepatico-jejunostomy reconstruction, re-transplantations, diagnosis of primary sclerosing cholangitis, reduced-size or split transplants, or significant donor or recipient duct size discrepancy, were excluded.
Eligible outcomes were safety (anastomotic bile leak or fistula, cholangitis, peritonitis, overall biliary morbidity, and biliary mortality) or efficacy (anastomotic and non-anastomotic stricture; need for postoperative choledocho-jejunostomy or need for balloon dilatation and endoscopic sphincterotomy; and stent for biliary stricture).
In included studies, T-tubes remained in place for a minimum of three months. Where reported, patients mean age ranged from 43.5 to 52.4 years, and the proportion of males ranged from 50.9 to 69.1%.
The authors did not state how many reviewers performed the selection.
Assessment of study quality
Methodological quality was assessed by two reviewers independently using the method developed by Jadad and Schulz, giving a quality score out of 5 points. Criteria used included: randomised study, allocation concealment, blinding and method of blinding, withdrawals, and loss to follow-up. Studies with a score of up to and including 2 points were considered ‘low’ quality; and those with a score of 3 or more were considered ‘high’ quality.
The authors did not state how many reviewers performed the quality assessment.
The number of events for each outcome were extracted in order to calculate odds ratio (OR) and 95% confidence intervals (CI). When necessary, authors were contacted for supplementary information.
Two reviewers performed the data extraction independently, with disagreements resolved by consensus.
Methods of synthesis
Odds ratios (ORs) were pooled using a fixed-effect model and a random-effects model if significant heterogeneity was found. Statistical heterogeneity was assessed using the χ2 test and I2 statistic; significant heterogeneity was indicated when p values were equal to or less than 0.05. Sensitivity analyses were performed by removing one study at a time from the meta-analysis. Publication bias was assessed using the method of Egger et al. Pooled analyses were performed for all study designs and for RCTs alone for some outcomes.
Results of the review
Nine relevant studies were identified (n=1,034 patients), including four RCTs (n=445 patients, range 60 to 180) and five comparative retrospective studies with a sequential design (n=589 patients, range 64 to 162). (There was a discrepancy between the text and baseline characteristics table for the total number of participants, the number used in this review is taken from the table.) Three RCTs scored 3 points on the Jadad scale (high quality) and one scored 2 points (low quality). Most studies had a mean follow-up time of 15 months or more.
There were no significant differences between the ‘with T-tube’ and ‘without T-tube' groups for: anastomotic bile leaks or fistulas (nine studies including four RCTs; I2=16.3%); choledocho-jejunostomy revisions (seven studies including three RCTs; I2=0%); dilation and stenting (seven studies including three RCTs; I2=37.5%); hepatic artery thromboses (three studies including two RCTs; I2=0%); re-transplantation (three studies including two RCTs; I2=0%); and mortality due to biliary complications (four studies including two RCTs; I2=0%).
The ‘without T-tube' group had statistically significantly better outcomes than the ‘with T-tube' group, with fewer episodes of: cholangitis (OR 4.30, 95% CI 1.51 to 12.24; four studies including three RCTs; I2=14.2%); and peritonitis (OR 6.75, 95% CI 1.20 to 37.91; three RCTs; I2=0%). The ‘without T-tube' group had a non significant trend for fewer overall biliary complications than the ‘with T-tube' group (OR 1.89, 95% CI 0.95 to 3.74; nine studies including three RCTs; I2=76.2%). The fixed-effect model for fewer overall biliary complications showed a statistically significant difference in favour of the 'without T-tube' group, but there were no statistically significant differences when a random-effects model was used. All the other results used a fixed-effect model. The ‘with T-tube' group had statistically significantly fewer anastomotic and non-anastomotic strictures (OR 0.43, 95% CI 0.27 to 0.70; nine studies including four RCTs; I2=3.5%) than the ‘without T-tube' group.
When separate pooled analyses for the RCTs were performed, the overall results did not change. Significant publication bias was found for the pooled analysis for all studies of dilation and stenting (p=0.01), and biliary complications (p=0.01), but this bias was not present for the pooled analysis of the relevant RCTs alone. Sensitivity analyses failed to identify any individual study as a source of heterogeneity.
Two studies addressed hospital resources and costs, finding the T-tube group required more radiological procedures, significantly longer hospital stay, and a higher number of ultrasound studies than the 'without T-tubes' group. One study found the diagnostic tests and treatment of T-tube related complications led to greater expenses and longer hospital stay. No cost figures were reported.
Although the use of T-tubes in orthotopic liver transplantation for choledocho-choledochal anastomoses had a favourable prognosis for anastomotic and non-anastomotic strictures, its use did not assure fewer interventions and had an unfavourable prognosis for cholangitis and peritonitis. The evidence gathered discourages the routine use of biliary T-tubes in orthotopic liver transplantation.
The review addressed a well-defined question in terms of participants, interventions, study design and relevant outcomes. Relevant databases were searched but only for studies published in English, so some relevant studies may have been missed. However, the authors did note that they had not found any studies published in another language and publication bias was assessed. Although data extraction was carried out with efforts to reduce reviewer error and bias, it was not reported whether this process applied to study selection or validity assessment.
Study quality was assessed using suitable criteria. Relevant study details were reported, but no details of loss to follow-up were given and reporting of patient characteristics was limited. Statistical heterogeneity was assessed and there was evidence for heterogeneity with one outcome (overall biliary complications). The statistical method used for the meta-analysis seemed appropriate; pooled analyses were performed for all studies and for certain outcomes for RCTs alone. Some comparisons had very wide confidence intervals. The authors acknowledged the small number of studies used in some analyses, and limitations with using non-randomised studies. Sensitivity analyses were also performed.
In view of some potential limitations arising from the review process and uncertainties about the overall quality of included studies, the extent to which the authors’ conclusions are reliable is unclear.
Implications of the review for practice and research
The authors did not state any implications for practice or research.
Sotiropoulos GC, Sgourakis G, Radtke A, Molmenti EP, Goumas K, Mylona S, Fouzas I, Karaliotas C, Lang H. Orthotopic liver transplantation: T-tube or not T-tube? Systematic review and meta-analysis of results. Transplantation 2009; 87(11): 1672-1680
Subject indexing assigned by NLM
Anastomosis, Surgical /adverse effects /methods; Choledochostomy /adverse effects /methods /standards; Disease Progression; Female; Gallbladder Diseases /epidemiology /mortality; Humans; Liver Transplantation /methods /mortality /physiology /standards; Male; Odds Ratio; Peritonitis /epidemiology /mortality; Postoperative Complications /epidemiology /surgery; Practice Guidelines as Topic; Quality Assurance, Health Care; Retrospective Studies
Date bibliographic record published
Date abstract record published
This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.