Choledocholithiasis is present in 6 to 12% of patients with cholelithiasis. The incidence increases with age; in patients above the age of 60, about 20-25%, have choledocholithiasis concurrently with symptomatic cholelithiasis 1. Choledocholithiasis often leads to added complications, such as obstructive jaundice, cholangitis, biliary colic and gallstone pancreatitis 2. For the patients with suspected common bile duct (CBD) stones, either preoperative endoscopic cholangiography or an intra-operative cholangiogram will confirm the presence of the bile duct stones 3. Surgeons, today, can extract the common bile duct stones using either the endoscopic method, by endoscopic retrograde cholangiopancreatography (ERCP), or surgically by an open common bile duct exploration or the laparoscopic method.

Laparoscopic common bile duct exploration allows stones to be extracted in the same setting and is becoming increasingly popular given it is safe, effective and is low in cost. Endoscopic sphincterotomy is the first step of a two part treatment, which is followed by laparoscopic cholecystectomy 4-5. If the laparoscopic options are not available and endoscopic sphincterotomy have been unsuccessful, open bile duct exploration is the treatment of choice 6. Furthermore, benefits of laparoscopic treatment for common bile duct stones compared to open bile duct exploration have not yet been proven 7.

Primary choledochorrhaphy or T-tube drainage are the two options that surgeons have, after common bile duct exploration. T- tube drainage is chosen over primary closure with the assumed risk reduction of complications by relieving the sphincter spasm post-operatively; it has been the preferred choice in modern surgical practice 8. T-tube drainage is performed for three reasons: post-operative decompression of the common bile duct avoiding possible obstruction; post- operative visualization of common bile duct by X-ray; extraction of common bile duct stones with a Burhenne steerable catheter 8-9. T-tube, however, is associated with complications such as biliary tract infection and biliary leak following insertion of the tube 10. Despite these complications, T-tube drainage requires the patient to have the T-tube in place for several weeks with reported decrease in quality of life and an increase in discomfort 11. In comparison, primary closure is associated with decreased post-operative complications, with no discomfort, a shorter hospital stay, and shorter duration to return to work 8, 10-11. Within the last three decades, a number of authors have published data on postoperative outcomes of primary choledochorrhaphy and T-tube drainage with varying reports of overall benefits 12-21.

The aim of this study was to analyze the outcomes of primary choledochorrhaphy and T-tube drainage after common bile duct exploration, using randomized clinical trials (RCT) from 1983 to 2012, in order to determine whether primary choledochorrhaphy should indeed be the choice of closure.

After searching and screening the databases, eight studies comparing primary choledochorrhaphy and T-tube drainage were identified and selected for the analysis 14-21. The eight studies that were selected comprised of 619 patients. In total, 313 patients that underwent Primary choledochorrhaphy were compared with 306 patients that underwent T-tube placement after common bile duct exploration. From the eight studies that were selected, five studies used the open common bile duct exploration technique 14-18 whereas three studies used laparoscopic method for common bile duct exploration 19-21. For the Eight studies that were analyzed, seven perioperative criteria were compared: mortality, retained bile duct stones, length of stay, overall complications, biliary leak, subhepatic collection, and positive bile culture.

Length of Stay
From the eight studies, four studies mentioned length of stay 16, 19-21. A total of 375 patients were included with 188 patients with primary closure and 187 with T-tube placement. Primary closure was associated with a statistically significant shorter hospital stay compared to T-tube placement (WMD 95% CI, – 1.09 [-1.59 to -0.60]; p < 0.0001).

Overall Complications
Six of the eight studies mentioned complications 14-16, 19-21. Complications included were any form of technical failure in either of the groups, biliary peritonitis, T-tube dislodgement, postoperative hemorrhage, pulmonary collapse, coronary infarct, postoperative pancreatitis, and leakage around the T- tube. Of the patients included, 245 underwent primary choledochorrhaphy and 233 received a T-tube placement. From the 245 patients with primary choledochorrhaphy, 25 patients were reported to have had some form of postoperative complication. Whereas, 46 patients from the 233 that received T-tube placement were reported to have had some form of complication postoperatively. This indicated that primary choledochorrhaphy was associated with decreased postoperative complications. This difference was statistically significant (OR 95% CI, 0.47 [0.28, 0.80]; p = 0.005)

Positive Bile Cultures
Three studies mentioned positive bile cultures in their studies 14, 15, 17. Bile cultures was deemed positive if any organisms such as Streptococcus agalactiae were found in the cultures, as reported in Marwah (2004) 15. Of the 220 patients included from the three studies, 117 patients underwent primary choledochorrhaphy and 103 received a T-tube placement. Following primary choledochorrhaphy, 14 patients had positive bile cultures, compared to 36 patients who received T-tube placement. This indicated that primary choledochorrhaphy had decreased incidence of biliary infection peri-operatively compared to T-tube drainage. This difference was statistically significant (OR 95% CI, 0.22 [0.10, 0.45]; p < 0.0001).

Mortality
Peri-operative mortality was defined as death occurring during hospitalization or within 30 days after surgery. All eight trials reported on peri-operative mortality 14-21. There were a total of 5 deaths that were reported from the 619 patients that underwent common bile duct exploration. Of the reported 313 patients who underwent primary closure, 1 patient death was reported whereas 4 patient deaths were reported from the 306 patients with T-tube placement. The deaths reported were lower following primary choledochorrhaphy, however, the difference between the two groups was not statistically significant (OR 95% CI, 0.44 [0.10, 1.81]; p = 0.25).

Retained Bile Duct Stones
Six studies 14-16, 19-21 reported bile duct retention postoperatively. A total of 478 patients were included; 245 underwent primary choledochorrhaphy and 233 received T- tube drainage. After primary choledochorrhaphy, 6 patients were reported to have retained bile duct stones compared to 10 patients after T-tube placement. Although the incidence of retained bile duct stones was lower following primary choledochorrhaphy, the difference was not statistically significant (OR 95% CI, 0.60 [0.23, 1.57]; p = 0.30).

Biliary Leak
Six studies 15, 16, 18-21 reported peri-operative biliary leak in the peritoneal drain. A total of 439 patients were included; 216 patients underwent primary choledochorrhaphy and 223 patients received a T-tube placement. A total of 18 patients were reported to have a bile leak, 6 following primary closure versus 12 patients following T-tube placement. Primary choledochorrhaphy showed decreased postoperative biliary leak compared to T-tube drainage. This difference, however, was not statistically significant (OR 95% CI, 0.58 [0.23, 1.42]; p = 0.23).

Subhepatic Collection
Six studies 14-16, 18-20 reported subhepatic bile accumulation after removal of the peritoneal drain. A total of 409 patients were included; 206 underwent primary choledochorrhaphy and 203 received a T-tube placement. Bile accumulation was reported in 3 patients following primary choledochorrhaphy and 3 patients after T-tube placement. The differences between the two groups were not statistically significant (OR 95% CI, 1.06 [0.30, 3.68]; p = 0.93).

Over the past few decades, there have been major developments in the management of gallstone-related diseases. The annual cost of medical care for gallstones is almost $6.5 billion (1.3% of U.S. health care costs) compared with chronic liver disease and cirrhosis ($1.6 billion), chronic hepatitis C ($0.8 billion), and diseases of the pancreas ($2.2 Billion) 24. A major development has been in the minimally invasive surgical approach. The first laparoscopic cholecystectomy performed by Muhe in 1985 radically changed the management of gallbladder and biliary disease, evolving from the open surgical approach to a minimally invasive one 25. The prognosis of cholelithiasis has greatly improved with the progress of surgical techniques and laboratory examinations. Endoscopic retrograde cholangiopancreatography (ERCP) has become widely available and a routine procedure, while open cholecystectomy has largely been replaced by a laparoscopic approach. The availability of endoscopic ultrasound further lowers the need for bile duct instrumentation, decreasing biliary morbidity 26. ERCP following suspicion of common bile duct stones can be both diagnostic and therapeutic; sphincterotomy and ductal clearance of the stones during ERCP is the preferred primary treatment. Intra-operative cholangiogram at the time of cholecystectomy can also identify stones in the common bile duct 27.

Figure 2: Forest plot of length of stay.

There are currently two methods of stone extraction in patients with choledocholithiasis: the aforementioned ERCP with or without sphincterotomy, or the surgical approach, including open common bile duct exploration or a laparoscopic method 12. Ludwig Courvoisier, a Swiss surgeon, who made an incision in the common bile duct and removed a gallstone, did the first surgical exploration of the common bile duct in 1890. Prior to the development of laparoscopic methods, patients only had the option to undergo open common bile duct exploration, with greater than 90% duct clearance. The open method involves a longitudinal incision of the duct, so as not to compromise the blood supply to the duct. The bile duct is cleared of stones with the use of Fogarty balloons, saline irrigation, stone forceps, and scoops placed into the biliary tract through the opening. Choledochoscopy can be utilized during and after the removal of the stones to evaluate the ductal system. A basket can also be used for stone removal. Open bile duct exploration is now used infrequently with the advancements in the field of minimally invasive surgery 28.

Laparoscopic common bile duct exploration (LCBDE) has now become the preferred method of CBD exploration, due to increasing experience in laparoscopic techniques and increased demand for single-procedure minimally invasive duct clearance. The success rates for ductal clearance are between 80-90%, comparable to open surgical methods 29. The technique of LCBDE is well described by Petelin 28, 29. Access to the biliary system is acquired, after obtaining a cholangiogram, either via a transcystic or transductal approach using a choledochotomy. Transcystic method involves gall bladder retraction towards the hemidiaphragm, followed by cystic duct dilation. Transductal method is favored for stones greater than 6 mm in diameter, intrahepatic stones, cystic duct diameter less than 4 mm, and either a posterior or distal cystic duct entrance 28, 29. Once the biliary tree has been accessed; irrigation enables common bile duct clearance. The administration of 1-2 mg of intravenous glucagon allows relaxation of sphincter of Oddi and facilitates the irrigation process. Fogarty type balloons can be inserted to extract the stones 27, 28, 29.

After open or laparoscopic choledochotomy, there are two options available to the surgeon for closure of the choledochotomy: Primary choledochorrhaphy, suturing to close the choledochotomy primarily, or T-tube drainage of the biliary tree. The criteria for T-tube placement include: for later study of the biliary system; decompression, if the biliary tree has not been cleared, or access to the biliary system for recurrent stones. There have been several complication reported with T-tube placement: dislodgement of the tube, bacteremia, fracture of the tube, and the possibility of bile leak and peritonitis at the time of T tube removal. The T-tube acts as a foreign body around which bile pigments and bile salts may precipitate 28-30. Residual bile duct stones and postoperative visualization of CBD, reasons for which the T- tube is employed, can be achieved with intra-operative choledochoscopy and postoperative ERCP.

There are many randomized controlled trials arriving at the same conclusion that primary closure of CBD was a safe alternative to the insertion of a T-tube 15, 19-20. Marwah et al (2004)15 and Lygidakis (1983)17 both concluded that there is increased morbidity and mortality associated with T-tube placement. They also concluded that the use of T-tube following routine choledochotomy is unnecessary and primary closure is more safe and physiological, however, the sample size of 40 patients in the trial was small 15.

Two meta-analysis using data from six studies were performed by Gurusamy et al with regards to primary closure versus T-tube drainage after either open or laparoscopic common bile duct exploration in 2007 31,32. They reached the conclusion that primary closure after CBD exploration seemed at least as safe as T-tube drainage. However, the number of patients included was small and recent studies were not included. The earlier studies prior to these advancements in minimally invasive surgery may not be applicable.

Figure 3: Forest plot of overall complications.

Another meta-analysis performed by Zhu QD et al 33 also compared the peri-operative complications after primary choledochorrhaphy and T-tube drainage. The meta-analysis included six studies from 1990 to 2010, including a total of 392 patients. This metal-analysis concluded that primary closure was favorable over T-tube drainage in prevention of post-operative complications and confirmed the safety and feasibility of primary closure after choledochotomy for choledocholithiasis.

Our meta-analysis was different from the aforementioned studies included RCTs from January 1983 to October 2012. This meta-analysis included more studies than Gurusamy et al 31,32 and Zhu QD et al 33; we further analyzed the benefits of primary choledochorrhaphy over T-tube drainage, adding seven more years to the meta-analysis. Our meta-analysis showed that a statistical difference existed in length of stay, overall complications, and positive bile cultures peri- operatively, favoring primary choledochorrhaphy over T-tube drainage. There was no statistical significance between the two in peri-operative mortality, biliary leak, subhepatic collection and retained bile duct stones.

Our meta-analysis showed that the difference for peri- operative mortality was not statistically significant (P = 0.25). Overall, 4 deaths occurred in the T-tube drainage groups compared to 1 death in primary closure groups. The only death in the primary closure group was attributed to acute myocardial infarction, which may be unrelated to the surgical technique. Marwah et al 15 attributed the cause of death in the T-tube drainage group to be secondary to rapidly spreading necrotizing fasciitis of abdominal wall and septicemic shock due to peri-tubal bile leakage 15. This further supports primary choledochorrhaphy over T-tube drainage after common bile duct exploration 33.

Our meta-analysis showed no statistical significance between primary choledochorrhaphy and T-tube drainage in biliary leak, subhepatic collection and retained bile stones. This raises the question whether the choice of closure of choledochotomy has an effect on whether there is a retained bile duct stone (P = 0.30). Several studies showed that retained bile duct stone rate was low because of intra- operative choledochoscopy 12, 21, 34. This no longer required the usage of T-tube drainage postoperative as the presence of a residual stone was confirmed by intra-operative choledochoscopy. Furthermore, postoperative ERCP could be used to treat the residual stones.

Our study demonstrated statistically significant difference for length of stay in the hospital (P < 0.0001), overall peri- operative complication (P = 0.005) and postoperative positive bile cultures (P < 0.0001). The decrease in hospital stay is favorable as it could save medical costs, decrease the time patients have to take leave from their work and also decrease the likelihood of nosocomial infections, especially in the elderly 33.

After carrying out the meta-analysis, primary closure did not increase the risk of bile leakage, subhepatic collection, mortality and retention of the bile duct stones. The patients are able to go home earlier after the primary closure and do not have the discomfort of T-tube drainage. In addition, patients require a functioning T-tube, for which they require a T-tube cholangiogram, further prolonging the hospital stay.

The present study has several limitations. The increased prevalence of pre-operative comorbidities generally observed among elderly populations potentially introduces significant selection bias when comparing post-operative outcomes with younger cohorts without similar physical histories. Also, the data utilized included several studies that were retrospective in References: design, leading to the potential introduction of additional selection bias. In addition, the outcome of any major abdominal surgery heavily depends upon the expertise and clinical experience of the operating surgeon, a highly qualitative factor which cannot be easily standardized. Several additional factors have also been shown to affect patient outcomes: pre-operative nutritional status, time since diagnosis, advanced status of the disease, which were not taken into account in several studies. Individual surgeon’s experience and institutional volume also affect the peri- operative outcome 34, which could not be assessed from their published data. A certain number of patients may choose not to undergo the procedure and this can lead to another selection bias. There have been several developmental improvements in operative outcome, such as minimally invasive surgery, the management of complications and critical care within the last three decades. Studies reported by many authors from 1980 to 2012 may further add to the information bias.

When any abdominal surgery is considered, a thorough preoperative assessment leads to a risk-benefit profile for the individual patient. Several previously identified comorbidities must be weighed against the potential benefits of the surgery. In general, every patient undergoing common bile duct exploration must be considered carefully on an individual basis and selected individually for primary choledochorrhaphy or T-tube drainage. As a result, it is the authors’ conclusion that it would be very difficult to conduct an adequate prospective randomized controlled trial evaluating this topic.

Our meta-analysis favors primary choledochorrhaphy over T- tube drainage after choledochotomy. It was found that primary choledochorrhaphy was associated with decreased peri-operative morbidity and mortality. There was a decreased incidence of overall complications postoperatively. It showed that patients did not have to go through the discomfort of having a T-tube placed and were able to go home earlier. The use of T-tube following routine choledochotomy is unnecessary. There is still a need to carry out a meta-analysis of a larger sample to further analyze the efficacy of primary choledochorrhaphy after common bile duct exploration.

1. Ko C, Lee S: Epidemiology and natural history of common bile duct stones and prediction of disease.Gastrointest Endosc 56:S165, 2002.
2. Hungness ES, Soper NJ (2006) Management of common bile duct stones. J Gastrointest surg 10:612.
3. Amouyal P, Amouyal G, Levy P, et al: Diagnosis of choledocholithiasis by endoscopic ultrasonography.Gastroenterology 106:1062, 1994.
4. Rhodes M, Sussman L, Cohen L, Lewis MP. Randomized trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones. Lancet 1998;351:159—161.
5. Cuschieri A, Lezoche E, Morino M, et al. EAES multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi Surg Endosc 1999;13:952—957.
6. Lilly MC, Arregui ME: A balanced approach to choledocholithiasis. Surg Endosc 15:467, 2001.
7. Tokumura H, Umezawa A, Cao H, et al. Laparoscopic management of common bile duct stones: transcystic approach and choledochotomy. J Hepatobiliary Pancreat Surg 2002;9:206-12.
8. Wills VL, Gibson K, Karihaloo C et al (2002) Complications of biliary T-tubes after choledochotomy. ANZ J Surg 72:177-180.
9. Burhenne HJ (1972) Non-operative retained biliary tract stone extraction. Calif Med 117:57.
10. Perez G, Escalona A, Jarufe N et al (2005) Prospective randomized study of T-tube versus biliary stent for common bile duct decompression after open choledochotomy. World J Surg 29:869–872.
11. Leida Z, Ping B, Shuguang W, Yu H (2008) A randomized comparison of primary closure and T-tube drainage of the common bile duct after laparoscopic choledochotomy. Surg Endosc 22:1595–1600.
12. Ambreen M, et al (2009) Primary Closure Versus T-tube Drainage After Open Choledochotomy. Asian Journal of Surgery 32:21—25.
13. Pérez G, et al (2005) Prospective Randomized Study of T-Tube versus Biliary Stent for Common Bile Duct Decompression after Open Choledocotomy. World J. Surg. 29, 869–872.
14. Williams JA, Treacy PJ, Sidey P, Worthley CS, Townsend NC, Russell EA. Primary duct closure versus T-tube drainage following exploration of the common bile duct. The Australian and New Zealand Journal of Surgery 1994;64(12):823–6.
15. Marwah S, Singh I, Godara R, Sen J, Marwah N, Karwasra RK. Evaluation of primary duct closure vs T-tube drainage following choledochotomy. Indian Journal of Gastroenterology 2004;23(6):227–8.15.
16. Payne RA, Woods WGA (1986) Primary suture or T-tube drainage after choledochotomy. Annals of the Royal College of Surgeons of England 68:196—198.
17. Lygidakis NJ (1983). Choledochotomy for biliary lithiasis: T-tube drainage or primary closure. Effects on postoperative bacteremia and T-tube bile infection. American Journal of Surgery 1983;146(2):254–6.
18. Makinen AM, Matikainen M, Nordback I. T-tube drainage is needed after routine common bile duct closure: results of a randomized trial. Surgical Research Communications 1989;6(4):299–302.
19. El-Geidie et al (2010) Is the Use of T-tube Necessary after Laparoscopic Choledochotomy?. J Gastrointest Surg 14:844–848.
20. Zhang L, et al (2008) A randomized comparison of primary closure and T-tube drainage of the common bile duct after laparoscopic choledochotomy. Surg Endosc 22:1595–1600.
21. Zhang WJ, et al (2009) Laparoscopic Exploration of Common Bile Duct with Primary Closure Versus T-Tube Drainage: A Randomized Clinical Trial. Journal of Surgical Research 157:e1–e5.
22. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, (1999) Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM statement. Lancet 54:1896—1900.
23. Ko, CW, Lee SP. Epidemiology and natural history of common bile duct stones and prediction of disease.Gastrointest Endosc 2002;56:S165- 169.
24. Litynski GS (1998) Erich Muhe and the rejection of laparoscopic cholecystectomy (1985): a surgeon ahead of his time. JSLS 2:341-346.
25. Williams EJ, et al (2008). Guidelines on the management of common bile duct stones (CBDS) Gut 2008;57:1004-1021.
26. Hamy A, Hennekinne S, Pessaux P, et al: Endoscopic sphincterotomy prior to laparoscopic cholecystectomy for the treatment of cholelithiasis. Surg Endosc 17:872, 2003.
27. Petelin JB. Laparoscopic common bile duct exploration. Surg Endosc 2003;17:1705–1715.
28. Petelin JB. Surgical management of common bile duct stones. Gastrointest Endosc 2002;56:S183–189.
29. Reinhoff WF (1960) Primary closure of the common bile duct. Ann Surg 151:255-260.
30. Gurusamy KS, Samraj K (2007) Primary closure versus T-tube drainage after laparoscopic common bile duct stone exploration. Cochrane Database Syst Rev CD005641.
31. Gurusamy KS, Samraj K (2007) Primary closure versus T-tube drainage after open common bile duct exploration. Cochrane Database Syst Rev CD005640.
32. Zhu QD et al (2011). Primary closure versus T-tube drainage after common bile duct exploration for choledocholithiasis. Langenbecks Arch Surg (2011) 396:53-62.
33. Chowdhury MM et al (2007). A systematic review of the impact of volume of surgery and specialization on patient outcome. British journal of surgery 2007; 94: 145-161.