The liver has various functions. Production of bile is one of these functions. Bile is necessary for digestion of fat and removal of certain waste byproducts from the liver. The bile produced in the liver is stored temporarily in the gallbladder. On eating fatty food, the gallbladder releases the bile into the small bowel. The common bile duct is the tube through which bile flows from the liver to the gallbladder, and from there to the small bowel. Stones can obstruct the flow of bile from the gallbladder into the small bowel. Usually such stones are formed in the gallbladder and migrate into the common bile duct. Obstruction of the flow of bile can lead to jaundice. Such stones are usually removed using an endoscope (by introducing an instrument equipped with a camera through the mouth and into the small intestine) before keyhole removal of gallstones (laparoscopic cholecystectomy) or as a part of the keyhole removal of gallstones (laparoscopic common bile duct exploration). Laparoscopic common bile duct exploration can only be performed in highly specialised centres and so endoscopic removal of common bile duct stones is the commonly used method to treat stones in the common bile duct. However, when such endoscopic treatment fails the patient has to be subjected to open common bile duct exploration. This involves exploring the common bile duct using instruments or a camera, or both, which are introduced into the common bile duct usually through a cut in the common bile duct. After the stones are removed, the hole in the common bile duct has to be stitched. Traditionally, surgeons have used a T-tube through the cut in the common bile duct. The T-tube is shaped like the English letter 'T' as the name indicates. The top part of the letter 'T' is inside the common bile duct while the long bottom part of the letter 'T' is brought out of the tummy through a small cut and is connected to a bag. This tube is inserted with the intention of preventing the build-up of bile in the common bile duct due to temporary swelling, which is common after any cut in any part of the body. The build-up of bile along with the swelling can potentially prevent healing of the bile duct resulting in leakage of bile from the common bile duct into the tummy. Uncontrolled bile leak into the abdominal cavity can be life-threatening if this is not recognised and treated appropriately. In addition to acting as a drain, draining the bile from the common bile duct to the exterior, dye can be injected into the T-tube and an X-ray used to demonstrate any residual stones. Once the absence of residual stones is confirmed, the T-tube is removed. However, surgeons are concerned about the tiny hole which the T-tube leaves on removal. This tiny hole in the common bile duct normally heals without a trace, but in some patients bile can leak through the hole and cause the very problem that the T-tube was meant to prevent. Thus the use of a T-tube after open common bile duct exploration is a controversial issue. We attempted to answer the question whether primary closure (stitching the cut in the bile duct without a T-tube) is better than using a T-tube after open exploration of the common bile duct by reviewing all the available information in the literature from randomised clinical trials. Randomised clinical trials are special types of clinical studies which provide the most valid answers if performed correctly.
We identified a total of six trials including 359 participants of whom 178 had primary closure and 181 patients had T-tube drainage after open exploration of the common bile duct. All six trials were at high risk of bias (risk of overestimating the benefits and underestimating the harms of the intervention or the control). There was no significant difference in mortality (12 deaths per 1000 participants in the T-tube drainage group versus 6 deaths per 1000 participants in the primary closure group) or in the serious complication rate after surgery between the two groups (approximately 145 complications per 1000 participants in the T-tube drainage group versus 66 complications per 1000 participants in the primary closure group). Although the number of deaths and complication rates in the primary closure group appeared to be less than half those in the T-tube group, there is a possibility that this was not a true observation but rather a difference that occurred by chance (similar to there being one chance in eight of flipping a coin and having it come up heads or tails three times in a row). For this reason we cannot be sufficiently confident that a true effect exists, and we term such a difference as not being statistically significant. None of the trials reported quality of life or the time taken for patients to return to work. The average operating time was significantly longer in the T-tube drainage group than in the primary closure group (by about 30 minutes). The average hospital stay was significantly longer in the T-tube group than in the primary closure group (by about five days). Use of a T-tube appears to increase the cost without providing any benefit to the patients. Further randomised trials with low risk of bias (low chance of arriving at the wrong conclusions because of prejudice by healthcare providers, researchers, or patients) and low risk of random errors (arriving at wrong conclusions because of chance) are necessary to confirm whether the use of T-tubes is justified anymore. Until the results from such trials are available, we discourage the routine use of T-tube after open common bile duct exploration.
T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.
Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Stones may be removed at the time of cholecystectomy by opening and clearing the common bile duct. The optimal technique is unclear.
The aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after open common bile duct exploration for common bile duct stones.
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2013.
We included all randomised clinical trials comparing T-tube drainage versus primary closure after open common bile duct exploration.
Two of four authors independently identified the studies for inclusion and extracted data. We analysed the data with both the fixed-effect and the random-effects model using Review Manager (RevMan) analyses. For each outcome we calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence interval (CI) based on intention-to-treat analysis.
We included six trials randomising 359 participants, 178 to T-tube drainage and 181 to primary closure. All trials were at high risk of bias. There was no significant difference in mortality between the two groups (4/178 (weighted percentage 1.2%) in the T-tube group versus 1/181 (0.6%) in the primary closure group; RR 2.25; 95% CI 0.55 to 9.25; six trials). There was no significant difference in the serious morbidity rate between the two groups (24/136 (weighted serious morbidity rate, 145 events per 1000 patients) in the T-tube group versus 9/136 (weighted serious morbidity rate, 66 events per 1000 patients) in the primary closure group; RaR 2.19; 95% CI 0.98 to 4.91; four trials). Quality of life and return to work were not reported in any of the trials. The operating time was significantly longer in the T-tube drainage group compared with the primary closure group (MD 28.90 minutes; 95% CI 17.18 to 40.62 minutes; one trial). The hospital stay was significantly longer in the T-tube drainage group compared with the primary closure group (MD 4.72 days; 95% CI 0.83 days to 8.60 days; five trials).