Abstract
Abstract
Background:
There are three choledochotomy closure methods available following laparoscopic common bile duct exploration: T-tube insertion, antegrade stenting, and primary choledochorrhaphy. We reviewed the experience of 12 years at our center searching for the optimal closure technique.
Methods:
We analyzed retrospectively 146 patients that underwent one of the three closure methods from February 2004 to March 2016. Hospital stay, need for readmission, incidence of early and long-term complications, and biliary leakage development and their clinical impact were determined for each technique.
Results:
Hospital stay was more prolonged, and need for readmission was higher in the T-tube group. Nine patients of the T-tube group (17.3%), 5 patients (8.6%) of the antegrade stenting group, and 1 patient of the primary suture group (2.8%) developed Dindo-Clavien ≥3 complications (P = .076). The incidence of biliary leakage was 3.8%, 8.6%, and 16.7% for the T-tube group, antegrade stenting group, and primary suture group, respectively. There was no grade C biliary fistula in the primary suture group, and all grade B leaks in these patients were only due to prolonged duration. The T-tube removal caused adverse events in 21.1% of the patients, and complications directly related with stents occurred in 9.6%.
Conclusion:
Antegrade stents or T-tube insertion do not provide any added value for choledochotomy closure but are charged with specific morbidity. On the contrary, despite biliary leaks being more frequent after primary suture, they are of little clinical consequence and may be managed on an outpatient basis.
Introduction
C
Materials and Methods
Patients
We performed a retrospective analysis of 168 patients who underwent LCBDE at our center from February 2004 to March 2016 following a diagnosis of choledocholithiasis. Informed consent was obtained from all individual patients included in the study who underwent the procedure. The management protocol at our institution for CBDS involves LCBDE for all the patients excluding only those that present without a dilated common bile duct (<9 mm) or had received a previous cholecystectomy. Endoscopic bile duct removal by ERCP is then conducted. Patients that are not fit for surgery because of a poor performance status are also referred for ERCP. At last, open surgery is only offered to patients not suitable for the laparoscopic approach following ERCP failure.
Operative technique
The three surgeons of the Hepatobiliary and Pancreatic Surgery Unit at our center performed all the procedures. The transcystic approach was only used in the presence of a short and dilated cystic duct with a single small stone distal to the cystic insertion. Otherwise, a supraduodenal longitudinal choledochotomy was always the preferred method for common bile duct (CBD) exploration. Following CBDS removal by a combination of saline irrigation, Dormia basket, or balloon extraction technique, the bile duct clearance was guaranteed by intraoperative fiber-choledochoscopy or cholangiography examination. The choledochotomy closure was achieved using one of the following three methods: if choledochorrhaphy protected by a T-tube was chosen, the drain was positioned at the edge of the choledochotomy and the bile duct closed around the tube using a running suture of absorbable 4-0. The long end of the T-tube was brought out of the abdominal wall through the sheath used for a right lateral 5 mm trocar. All inserted T-tubes were gutter fashioned rubber drainages sized from 10F to 16F. Bile spillage around the T-tube was always discarded by saline irrigation before surgery was concluded. If antegrade biliary stenting was the preferred closure method, a 6–8.5F plastic biliary stent was inserted in the choledochotomy and passed throughout the papilla by gentle pushing. If necessary, a Fogarty catheter was used as a guide employing a Seldinger technique. The correct placement of the stent throughout the papilla was always assured by intraoperative fiber-choledochoscopy. Choledochotomy was then closed using a running suture of absorbable 4-0. Bile spilling was discarded by transcystic saline irrigation. At last, in those patients in which primary choledochorrhaphy was conducted, the above described running suture of absorbable 4-0 was the single surgical gest performed. The determination of the bile duct closure methods was made by preference of the surgeon in charge of the procedure. At the beginning of the study period, T-tube insertion was the institutional policy for bile duct closure. Since 2006, antegrade stenting was introduced and replaced the previous technique as the preferred method. In recent years, primary choledochorrhaphy has gained favor as the most used technique at our center. Thus, at present, whenever possible, primary bile duct closure is performed routinely. If concern about the correct emptying of the papilla is stated, antegrade stenting is recommended. If stent placement is unsuccessful, a T-tube insertion is considered. A suction drain is always left on place at the end of surgery.
Postoperative care and hospital discharge
Early mobilization and resumption of oral intake was carried out a few hours after surgery. The patients who underwent a primary CBD closure or antegrade stenting were discharged from hospital 24–48 hours following surgery once the suction drain was removed in the absence of bile spillage. Otherwise, if the patients are still asymptomatic, the drain could be controlled on an outpatient basis, scheduling visits every week until the biliary fistula was closed and the drain could be finally withdrawn. T-tube drains were left open for 72 hours, and a trans-Kehr cholangiography was performed on the 3rd to 7th postoperative day. The T-tube was then clamped either daily progressively in the first cases or completely 24 hours after cholangiography in the latter patients if absence of residual stones and good emptying of the contrast into the duodenum were stated. Patients were then discharged from hospital.
Follow-up schedule and T-tube and antegrade stent removal protocol
Postoperative follow-up visits were scheduled 1 and 6 months after surgery to check the clinical status of the patients, obtain liver function laboratory tests to exclude cholestasis, and remove T-tube or antegrade stents.
Based on the published experience of the authors demonstrating that the laparoscopic approach impairs and delays sinus track formation, 24 the T-tube was always removed at least 1 month after surgery on an outpatient basis. Patients who had a stent inserted underwent an abdominal X-ray examination and if the stent was still present, endoscopic removal was conducted the same day of the first follow-up visit.
Data collection
Demographic data before surgery were collected and included age, gender, body mass index, comorbidity, and history of previous abdominal surgery. The clinical presentation features and the anesthetic risk following the American Society of Anesthesiologists (ASA) were also registered. The preoperative diameter of the CBD, number of CBDS removed during the procedure, method used for CBD clearance, presence of intrahepatic stones or impacted stones at the papilla, and need to convert to open surgery were analyzed.
The postoperative complication development was determined following the validated classification system by Dindo-Clavien.25,26 Since Kehr drain removal is charged with morbidity by itself, the same classification was used to state T-tube related adverse events. Bile leakage was defined according to the standard criteria of the International Study Group of Liver Surgery (ISGLS) as fluid with bilirubin concentration at least thrice greater than serum bilirubin in the abdominal drain or in the intra-abdominal fluid on or after postoperative day 3, or as the need for radiologic or surgical intervention because of biliary collections. Severity of bile leaks was categorized following the same classification in grade A, B, and C fistula, 27 and the clinical consequences of those leaks were graded using the Dindo-Clavien scale. Data about the need for reoperation, mortality, average hospital stays, and readmission requirement after hospital discharge were also analyzed. At last, presence of late biliary complications described as recurrent lithiasis occurrence or CBD stenosis development following surgery was also recorded. As previously described, we defined recurrence of choledocholithiasis as the development of stones not earlier than 6 months after the complete removal of the initial CBDS.28–31
Statistics
All quantitative values were expressed as the median and range. Categorical variables were presented as values and percentages. The relationship between the bile duct closure technique and all the variables of the study was analyzed using the Chi-square and the nonparametric Kruskal–Wallis test as appropriate. P values <.05 were considered statistically significant. Statistical analysis was performed using the SPSS for Mac v.20 software program.
Results
A total of 168 patients were operated on a one-step totally laparoscopic approach for CBDS removal. Four patients who underwent a transcystic extraction and two patients who received a choledochoduodenostomy were not included in the study. Sixteen patients (9.9%) who had to be converted to open surgery during LCBDE were also excluded. Finally, a total of 146 patients were analyzed. Choledochorrhaphy protected by a T-tube was performed in 52 patients (35.6%), while 58 patients (39.7%) underwent CBD closure after antegrade stenting and 36 patients (24.7%) received a primary suture. Comparison of demographic data, clinical presentation features, and characteristics of the choledocholithiasis extraction and CBD size among the three groups are listed in Table 1. Prior abdominal surgery was more frequent in the primary suture group. Global success rate for CBD clearance was 97.9%, while residual choledocholithiasis was detected in 2.7% of the patients in the first 6 months after surgery. Hospital stay was significantly superior for the T-tube compared to the group showing a median of 11 days (range 4–70) in comparison with the antegrade stenting group (median of 4 days, range 1–57 days) and the primary suture patients (median of 3 days, range 2–30 days) with a P value of .0005. There were no statistical differences when only the two latter groups were compared (P = .468).
Values of quantitative variables are expressed as the median and range in brackets. Qualitative variables are expressed as values and percentages.
Reach statistical differences.
ASA, American Society of Anesthesiologists; CBDS, common bile duct stones.
General morbidity by groups
Nine patients of the T-tube group (17.3%), 5 patients (8.6%) of the antegrade stenting group, and 1 patient of the primary suture group (2.8%) developed major complications (Dindo-Clavien ≥3) following surgery (P = .076). Need for hospital readmission was more frequent in the T-tube group and occurred in 9.6% of the patients while only in 5.2% of the antegrade stenting group. No patients of the primary suture group had to be hospitalized after hospital discharge. Reoperation was necessary in 3 patients (5.8%) of the T-tube group and 2 patients (3.4%) of the patients who received a stent but in none of the patients who underwent a primary choledochorrhaphy. There was no mortality directly associated with the surgical technique. However, 1 patient (0.7%) died because of a hemorrhagic stroke during the postoperative period. The complete data about postoperative complications are listed in Table 2.
Qualitative variables are expressed as values and percentages.
Biliary complications
The incidence of biliary leakage was 3.8% (2 patients) in the T-tube group, 8.6% (5 patients) in the antegrade stenting group, and 16.7% (6 patients) in the primary suture group. Differences were only statistically significant if the T-tube group was compared with the primary suture group (P = .047). However, patients who underwent a primary choledochorrhaphy developed no grade C biliary fistula and all the grade B biliary leaks were actually due to a prolonged duration of more than a week according to the ISGLS criteria and did not need therapeutic interventions (Dindo-Clavien grade I complication). If grade A biliary fistula was excluded of the analysis, there were no statistically significant differences among the three groups with an incidence of grade B + C leaks of 9.6%, 6.9%, and 11.1% for the T-tube group, antegrade stenting group, and primary suture group, respectively (P = .765) (Table 3).
According to the ISGLS classification.
Qualitative variables are expressed as values and percentages.
ISGLS, International Study Group of Liver Surgery.
Group-specific complications
The T-tube removal caused adverse events in 11 patients (21.1%), although 8 patients suffered only mild complications consisting in isolated febrile peaks in 2 patients (3.8%), short-lasting abdominal pain requiring only analgesia in 3 patients, and self-limited biliary fistula in 3 patients (5.7%). Sinus tract formation was incomplete in further three cases leading to a biliary peritonitis development after T-tube withdrawal and the need for reoperation for lavage and drainage. Complications directly related with the inserted stent occurred in 5 cases (9.6%) since 4 patients had their stent migrated into the CBD requiring endoscopic extraction and 1 patient developed a small bowel perforation caused by the spontaneously eliminated stent weeks after LCBDE and had to be reoperated.
Long-term complications
Incidence of CBDS recurrence following LCBDE was of 5.8% (3 patients) in the patient who underwent a T-tube insertion, of 7.0% (4 patients) in those who received antegrade stenting, and of 4.2% (1 patient) in the cases whose choledochorrhaphy technique was a primary suture revealing no statistical differences (P = .882). Only 1 patient of the antegrade stenting group developed a biliary stenosis requiring new stenting conducted by an ERCP performance (P = .451).
Discussion
At present, there is enough evidence supporting that LCBDE is at least equally effective for CBDS removal and is charged with equivalent morbidity rates than ERCP plus ES.1,11–14 However although studies showing superiority of LCBDE in terms of lower recurrent CBDS rates, 10 shorter hospital stay, and better cost effectiveness 9 could be cited, it is uncontrovertibly true that ERCP is more popular for the treatment of choledocholithiasis in most centers. A recent nationwide survey performed in the United States concluded that 86% of the surgeons chose ERCP for preoperatively known CBDS. 32 Many reasons have been advocated for this preference: having a reliable ERCP proceduralist available, lack of suitable equipment for LCBDE, or lack of comfort performing the single stage approach. The difficulty in finding the perfect method for bile duct closure is one of the reasons because many surgeons do not feel comfortable with LCBDE. Since first used by Kehr, the T-tube has been used in open surgery for over a 100 years to prevent biliary leakage and bile duct stenosis following choledochotomy. 33 With the onset of laparoscopic surgery the first CBD closure method was directly inherited from open surgery, and T-tube insertion was the rule after LCBDE. However, the need for a T-tube to prevent biliary stenosis is a surgical myth that has been left behind. Although seldom reported, our study, according to the literature,34,35 reveals that no differences in long-term CBD stricture development were found among the three groups of choledochorrhaphy. In contrast, T-tube insertion is clearly charged with specific morbidity.36,37 The presence of an external communication with the bile duct favors exogenous acquisition of environmental microorganisms, 38 and cholangiographies performed through the T-tube may also increase infection. 39 In addition, as previously published by the authors, sinus tract formation is impaired following laparoscopic surgery and even despite delayed removal of the drain is scheduled, we reveal how considerable morbidity still appears following T-tube withdrawal.37,40,41 With little advantages and increased morbidity, we do not recommend the use of T-tubes and at present the technique is seldom used at our center.
The fear for bile leakage development following CBD closure led to incorporate stent insertion, directly merged from the ERCP procedure. The assumption that the manipulation of the papilla during CBDS extraction could cause spasm or inflammation and therefore impair correct bile drainage causing biliary hyperpressure and filtration throughout the choledochorrhaphy made many surgeons choose antegrade stenting instead of primary suture as the preferred bile duct closure method. However, although biliary spillage occurred more frequently following primary choledochorrhaphy, our study reveals that bile leaks were of little clinical impact in patient management. There was no grade C fistula, and all the grade B leaks were actually due to a prolonged duration with no need for therapeutic intervention. None of these patients suffered a delayed hospital discharge because of their biliary fistula and had their drain removed during an outpatient visit. In fact, bile leaks in the primary suture group resulted only in Dindo-Clavien grade 1 complications. Having a global view of the issue, neither T-tube nor plastic transpapillary stent insertion provide any added value in CBD closure. As we state in our study, they do not prevent biliary narrowing, since stenosis rarely occurs after choledochorrhaphy if the size of the bile duct is at least of 9 mm. Bile leaks may be somehow reduced by diminishing CBD pressure during wound healing, but the clinical impact of the mild biliary leaks in the primary suture group was irrelevant. In contrast, adverse effects related to the T-tube insertion, dislodgment, or removal were significant and at least 6 patients developed specific morbidity caused by the stent itself that could have been avoided if a primary choledochorrhaphy would have been chosen. As a conclusion of our study, at present, there is little place for T-tube or stent insertion following LCBDE. We state that primary choledochorrhaphy should be the preferred option for bile duct closure. Patients who undergo this technique may be advised of the possibility of some bile leak that could be managed on an outpatient basis protocol without further clinical consequences.
Footnotes
Disclosure Statement
No competing financial interests exist.
