Summary of main results
This systematic review shows that T-tube drainage might increase the operating time and hospital stay without any evidence of difference in serious complications. One of the reasons for considering the employment of T-tube drainage is to decompress the common bile duct if there is distal obstruction (Williams 1994). This is to avoid bile leak and bile peritonitis. In the three trials including 148 patients allocated to the primary closure group (Leida 2008; Zhang 2009; El-Geidie 2010), the biliary complications in the primary closure group included one patient with bile leak requiring endoscopic stent (Zhang 2009), one patient with bile leak requiring percutaneous drainage (Leida 2008), and another patient developing biliary pancreatitis requiring endoscopic stent (Leida 2008). In contrast, of the 147 patients belonging to the T-tube closure group in the three trials (Leida 2008; Zhang 2009; El-Geidie 2010), the biliary complications included seven patients who required open re-operations for bile peritonitis, T-tube dislodgement, or bleeding from the choledochotomy wound, three patients requiring percutaneous drainage for bile leak, and one patient developing acute pancreatitis which settled without any surgical, endoscopic, or radiological intervention (Leida 2008; Zhang 2009; El-Geidie 2010). Thus, there is no evidence that the T-tube is preventing bile leaks. There is also no evidence that the proportion of patients with serious morbidity or serious morbidity rates were different between the two groups. Long-term follow-up is necessary to detect any bile strictures and recurrence of common bile duct stones. There is no current evidence to suggest that these will be different between the groups.
Another reason for considering T-tube drainage is to extract any residual stones through the T-tube tract (Williams 1994). Even if patients develop symptomatic retained stones, endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy can be used for the treatment. Before the advent of endoscopic sphincterotomy, percutaneous transhepatic biliary drainage or open exploration were the only options available for the treatment of such patients. Although T-tube drainage to facilitate extraction of stones may have been appropriate in the past, this has become redundant with the currently available treatments.
The operating time was significantly longer in the T-tube group than in the primary closure group. This is expected because the T-tube involves additional steps during surgery.
The post-operative hospital stay was significantly longer in the T-tube group than for the primary closure group. The patients were discharged home with the T-tube in situ in all three trials included in this review (Leida 2008; Zhang 2009; El-Geidie 2010). So, the differences in the post-operative hospital stay cannot be explained by a delayed discharge for T-tube cholangiogram. While there was no significant difference in the serious morbidity rates between the two groups, this may be due to lack of evidence of effect rather than lack of effect. In the absence of any other explanation for the prolonged post-operative hospital stay, one has to conclude that the longer hospital stay in the T-tube group than primary closure group is due to higher morbidity.
The time taken to return to work was significantly longer in the T-tube group than for the primary closure group. This may be related to the presence of the T-tube itself which may discourage the patient to return to work or may be related to associated morbidity. As mentioned previously, lack of evidence of significant differences in serious morbidity should not be considered as evidence for lack of effect. The confidence intervals were wide and there is a possibility that this finding of lack of significant differences in serious morbidity rates could be because of lack of evidence of effect. Quality of life, another patient-oriented outcome, was not reported in any of the trials included in this review.
A longer post-operative hospital stay is neither beneficial to the patient (particularly in a private healthcare funding set-up) nor to the healthcare provider (particularly in a state-funded or insurance company funded healthcare funding set-up). In addition to the shorter hospital stay, the other cost-savings that can be made in the primary closure include the cost of the T-tube, increased operating time, the cost of T-tube cholangiogram, and the cost of removal of the T-tube. Unless these costs can be offset by decreased complications, the costs associated with the use of a T-tube cannot be justified. Based on the evidence from this review, this does not appear to be the case. Consequently, there appears to be little justification in the use of a T-tube after laparoscopic common bile duct exploration.
It appears that T-tube use has a significant potential to harm the patients and increase the costs for the healthcare funder without any notable benefit based on the information obtained from the trials included in this review. There is additional corroborative information. We identified three non-randomised studies comparing T-tube with primary closure (Ha 2004; Jameel 2008; Noh 2009) from the search strategy. None of the studies reported any biliary peritonitis (T-tube drainage: 0/26 (0%) (Ha 2004); 0/11 (0%) (Jameel 2008); 0/33 (0%) (Noh 2009) versus primary closure: 0/12 (0%) (Ha 2004); 0/48 (0%) (Jameel 2008); 0/30 (0%) (Noh 2009)). In addition, in another Cochrane review, which included 359 patients from six trials, we found that T-tube closure had longer operating time and hospital stay than primary closure of the common bile duct without stent after open common bile duct exploration, without affecting the serious morbidity rates significantly (Gurusamy 2013). In that Cochrane review of T-tube drainage versus primary closure in patients undergoing open common bile duct exploration, fewer patients developed biliary complications requiring intervention (not statistically significant) (Gurusamy 2013) as is the case with this review. The purpose of T-tube drainage is the same whether the patients undergo open or laparoscopic common bile duct exploration. Thus, there is a strong corroborative evidence that supports the findings of this review.
Overall completeness and applicability of evidence
This review is applicable in only patients undergoing laparoscopic common bile duct exploration for common bile duct stones and without distal obstruction to the flow of bile.
Quality of the evidence
Although the risk of bias in the included trials was high and the overall quality of evidence was very low, one has to put this into perspective. This is currently the best available evidence. The previous routine use of T-tube was based on clinical opinion and the fact that a significant proportion of the patients had to undergo major re-operations where stones were left in the bile duct. The advent of endoscopic sphincterotomy appears to have made the use of the T-tube redundant. The trials were at high risk of bias (for example, outcomes such as hospital stay and return to work can be biased because of lack of blinding and absence of any criteria for discharge from hospital or return to work, and a surgeon favouring primary closure might have discharged the patient from hospital earlier or might have advised the patient that he or she could return to work earlier) and new trials are necessary to assess whether T-tube drainage is better than primary closure after laparoscopic common bile duct exploration, as shown by the trial sequential analysis. Until such new trials with low risk of bias show that T-tube use is safe and effective, the use of T-tube after laparoscopic common bile duct exploration should be confined to randomised clinical trials. Such randomised trials should include quality of life and return to work as these outcomes are useful to determine whether T-tube is beneficial to the patient and whether it is cost-effective.
Potential biases in the review process
We have followed the Cochrane methodology for performing the review. One potential bias was that we imputed the mean and standard deviation from median and other measures such as P values or inter-quartile ranges. This may have introduced an error in the effect estimate. The sensitivity analysis by excluding the trials in which the imputation was performed did not change the results. The alternative to this imputation is to present the information as presented by the authors, but the interpretation of that information can be even more confusing.
Agreements and disagreements with other studies or reviews
In the previous version of this review, we stated that we could not make any conclusions because of the data available at that time (Gurusamy 2007). In this review, we advocate against the use of T-tube outside well-designed randomised clinical trials.