An endoscopic sphincterotomy is scheduled to remove a gallstone lodged in the common bile duct

Introduction

Common bile duct (CBD) stones are the second most frequent complication of cholecystolithiasis, occurring in ∼5% of asymptomatic patients with a normal diameter bile duct on transabdominal ultrasound scan at the time of cholecystectomy, and in 10–20% of patients with symptomatic gallstones [12]. Treatment is advisable to prevent further complications, such as obstructive jaundice, acute cholangitis, and pancreatitis [3]. Open cholecystectomy and CBD exploration were standard strategies for patients with gallstone disease associated with CBD stones within the pre-endoscopy era. Together with the advancement of endoscopic and laparoscopic techniques, the CBD stones were removed preoperatively with endoscopes, which have been accompanied by laparoscopic cholecystectomy (LC) [4]. With all the breakthrough of endoscopic retrograde cholangiopancreatography (ERCP), endoscopic stone removal grew to become the treating preference before cholecystectomy for patients with CBD and gall bladder (GB) stones [5]. The current treatment of CBD stones remains controversial with debate between ERCP and CBD exploration. Management options range from a single-stage procedure in the form of laparoscopic common bile duct exploration (LCBDE) and cholecystectomy to other options in relation to ERCP before, during, or after cholecystectomy [678910]. LC and LCBDE are performed in a single session to treat choledocholithiasis, the procedure is associated with a shorter hospital stay and is more cost-effective compared with ERCP and endoscopic sphincterotomy followed by a cholecystectomy [11121314]. Laparoscopic transcystic bile duct exploration is the first-choice treatment for CBD stones, as the outcome is not dissimilar to that of ERCP [15]. Transcystic stone clearance is underused, perhaps because of the lack of expertise and/or local logistical and resource restrictions [16171819]. However, treating CBD stones by means of transcystic CBD exploration with LC in a single session can be used in a large percentage of patients. This approach, when available, helps to avoid the well-documented short-term complications of therapeutic ERCP and the long-term consequences of endoscopic sphincterotomy, particularly the high incidence of recurrent bile duct stones [20].

The aim of this study was to compare the results of total laparoscopic transcystic common bile duct exploration (LTCBDE) and stone extraction together with cholecystectomy and traditional ERCP followed by LC in two stages in the management of CBD stones associated with GB stones.

Patients and methods

This prospective randomized clinical study was carried out in Al Ahli Hospital, Qatar and AL Amiri Hospital, Kuwait, between December 2010 and December 2015. It included 252 patients with concomitant GB stones and CBD stones who were divided into two equal groups: group A (126 patients) underwent LTCBDE and LC in one stage, and group B (126 patients) underwent ERCP for CBD stone extraction followed by LC after 2–3 days in two stages.

The protocol was approved by an ethics committee. An IRB form and written consent form was obtained from all patients for the surgery and consent to share in this study after detailed explanation of the procedures and its possible complications.

The main inclusion criteria were as follows: age between 20 and 70 years with GB stones and concomitant CBD stones confirmed by means of abdominal ultrasonography or magnetic resonance cholangiopancreatography (MRCP); dilated CBD more than 8 mm in diameter; and elevation of one or more of the following laboratory results (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transpeptidase, and total and direct bilirubin).

Exclusion criteria were as follows: age above 70 years, pregnancy, acute cholecystitis, acute cholangitis, acute pancreatitis, CBD less than 8 mm in diameter, liver cirrhosis, a history of hepatobiliary surgery, previous ERCP, and American Society of Anesthesiology class 4 and 5 disease.

All patients of our study were evaluated clinically before the operation and underwent standard laboratory investigations (complete blood count, prothrombin time, partial thromboplastin time, international normalized ratio, liver function tests, serum amylase, and lipase), as well as radiological study, including abdominal ultrasonography and MRCP that was performed routinely for all cases with suspected CBD stones (elevated bilirubin and liver enzymes or ultrasound suspicion of CBD stones) (Figs. 1 and 2). They were randomized using sealed envelopes to undergo either one-stage or two-stage treatment.

Operative technique of one-stage LTCBDE and LC

The patients were started on prophylactic broad-spectrum intravenous antibiotics with third-generation cephalosporin at the time of induction. The antibiotics were continued for 48 h and then switched to oral antibiotics for 5 days.

A three-port cholecystectomy (one 11 mm umbilical and two 5 mm ports, epigastric and right hypochondrial) was used. Transcystic intraoperative cholangiogram was performed, after distal clipping of the cystic duct, using a cholangiography catheter (CC) (ureteric catheter 5 Fr, open-end straight tip, 70 cm long; Cook Ireland Ltd, Limerick, Ireland) within a cholangiography cannula inserted through a cholangiography forceps from the epigastric port with clamping of the cystic duct around the CC. Occasional resistance offered by valves in the cystic duct can, in most cases, be overcome by injecting saline as the CC is advanced, or with gentle stretching using the tip of a curved grasper to enable introduction of the CC (Figs. 3456).

When CBD stones are discovered at intraoperative cholangiogram, transcystic duct clearance is attempted with a Dormia basket inserted into the cholangiography cannula through the epigastric port. The insertion and advancement of the Dormia basket is carried out by the surgeon, whereas opening and closing is carried out by the assistant or the scrub nurse. Once the basket is opened, it is advanced to feel the lower end of the bile duct where gentle shaking of the basket traps the CBD stone. Advancing and withdrawing the Dormia basket at a length range of about 5 cm is carried out with the left hand. Gentle compression of the common hepatic duct using a blunt grasper or the tip of the suction probe aims at preventing stones from slipping proximally into the hepatic duct. The Dormia basket is pulled back to extract the stone. As soon as the basket with the stone in it comes into the CD, the cholangiography cannula is advanced close to the basket for better control over the trapped stone before it is taken out of the cystic duct opening, to avoid losing it. The stone is taken out of the basket and appropriately secured (Figs. 789).

We recommend repeating the technique until three consecutive attempts are negative (i.e. basket comes back empty of a stone), followed by a completion cholangiography. Occasionally, stones may be too large and impact the cystic duct on withdrawal. The options to deal with this are as follows.

1. Extending the opening of the cystic duct longitudinally toward the CBD if the cystic duct stump allows.
2. Fragmenting/crushing the stone with grasping forceps or with the basket surrounding the stone.
3. A combination of (1) and (2).

When the surgeon feels that the CBD and cystic duct stump are cleared, he or she may advance the CC into the duodenum as this adds more assurance that no small stones are lodged at the ampulla. Duct clearance is checked using completion cholangiography.

The cystic duct is ligated using an endoloop following the confirmation of clearance. Thereafter, cholecystectomy is completed by dissecting the GB from its bed using diathermy hook. Drain was inserted in the subhepatic region.

Technique of endoscopic stone extraction

The ERCP technique was carried out as a day-care procedure. All patients were fasting on the morning of the procedure. The procedure was performed with the patient under intravenous sedation. The ERCP procedure was performed with a side-viewing duodenoscope (TJF160R; Olympus, Gurgaon, Haryana, India). Selective cannulation of the bile duct was achieved using a wire-guided sphincterotome and a hydrophilic guidewire (260 cm, 0.032-inch diameter; Terumo, Trivandrum, Kerala, India). After guidewire-assisted cannulation, a contrast dye was injected to confirm the presence of CBD stones (Fig. 10). For extraction of the stones, a biliary sphincterotomy was performed using a combination current of cutting and coagulation (Endocut; Erbee, Tuebingen, Germany). The stones were extracted with the help of a Dormia basket or an extraction balloon (Fig. 11). A check cholangiogram was performed to confirm complete clearance of the bile duct. The patients were kept under observation for 6–8 h after the procedure. Any complications such as perforation, bleeding, pancreatitis, or cholangitis were noted. The patients were given preprocedure, oral, broad-spectrum antibiotics from the day before the procedure to 5 days after the procedure. After endoscopic extraction of the CBD stones, the patients underwent LC after 2–3 days.

All of the patients were scheduled for postoperative follow-up at 1 week, 1, 6 months, and up to 1 year or at any time if symptoms developed. The presence of pain and its severity, condition of the wound, history of jaundice, and any other problems were noted. At 1-month follow-up, liver function tests and abdominal ultrasound were performed to assess the status of the CBD.

The primary endpoint was success of the procedure, which was defined as removal of CBD stones and GB using the intended procedure. In group A, failure of the procedure was considered if CBD exploration and stone extraction were not completed laparoscopically. In group B, failure of the procedure was considered if CBD stones could not be extracted by means of ERCP or the GB could not be removed by means of laparoscopy.

Secondary endpoints included the following:

1. Operative time in minutes.
2. Hospital stay in days (in group B, the hospital stay was the sum of the admission days for the both ERCP and LC).
3. Pain score according to a visual analog scale ranging from 1 to 10 at 24 h, 1, and 6 weeks postoperatively.
4. Cost of the procedure, which included the hospital admission days, operative time, consumables and materials, perioperative medications, and perioperative laboratory and radiological investigations; cost of procedure was calculated by the billing and finance department and the value was considered in US dollars.
5. Patient satisfaction score: Patient satisfaction was scored on a verbal rating scale, with scores of 0 (not satisfied), 1 (partially satisfied), 2 (satisfied), and 3 (very satisfied) and recorded at a 6-week follow-up evaluation.
6. Complications.

Statistical analysis

The two different groups were compared using the χ2-test for qualitative variables and a parametric t-test to compare means for quantitative variables. Performance and safety were evaluated using the χ2-test. The software used was SPSS, version 11.0 for Windows (SPSS Inc., Chicago, Illinois, USA).

Results

Two hundred and fifty-two patients were enrolled in this study. They were divided into two equal groups: group A (126 patients) underwent LTCBDE and LC in one stage, and group B (126 patients) underwent ERCP for CBD stone extraction followed by LC after 2–3 days in two stages.

Both groups were similar in age, sex, and presenting symptoms (Table 1). Furthermore, both groups were similar in preoperative laboratory results, number, and size of CBD stones (Table 2).

In the one-stage procedure (group A), laparoscopic transcystic CBD stone extraction with cholecystectomy was successful for 116 of 126 (92.06%) patients. After CBD stone extraction, operative cholangiography was performed to ensure free passage of the dye to the duodenum and absence of further CBD stones.

Ten cases of 126 (7.94%) were converted to open CBD exploration and stone extraction followed by T-tube and drain insertion. The T-tube was removed after 10 days following T-tube cholangiography, and the drain was removed on the next day. The reasons for conversion were duodenal injury (one patient), injury to the posterior wall of the CBD (one patient), severe adhesions (three patients), bleeding (two patients), and impacted stone (three patients).

Five patients in group A with a diagnosis of retained CBD stones during follow-up evaluation were also considered as failures, and all of them subsequently underwent successful ERCP and stone clearance. Thus, the actual success rate was 111 of 126 patients (88.1%).

In the two-stage procedure (group B), ERCP was successful for 106 of 126 patients (84.1%). More than one attempt for complete clearance of the CBD was required for 12 patients (9.5%). This was followed by LC after 2–3 days. LC was completed for 101 of 106 patients (95.3%), and converted to open cholecystectomy in five cases (4.7%). The causes of conversion were bleeding (three cases) and dense adhesions (two cases).

In the remaining 20 patients (15.9%), CBD stones could not be cleared by means of ERCP. The causes of ERCP failure were inability to identify the papilla (six patients), unsuccessful cannulation (five patients), inability to remove impacted CBD stones (seven patients), and duodenal perforation (two patients). Eleven of them underwent successful laparoscopic transcystic CBD stone extraction and cholecystectomy. The two cases of duodenal perforation underwent laparotomy with repair of duodenal perforation, choledochotomy, and stone extraction with cholecystectomy and insertion of T-tube and drain. Seven patients with impacted CBD stones were converted to open CBD exploration and stone extraction with cholecystectomy after failure of removal of the CBD stones through the laparoscopic transcystic approach. The CBD was closed over T-tube and a drain was inserted in the subhepatic region. After 10 days, T-tube cholangiography was performed and proved clear patent CBD with free passage of the dye to the duodenum; T-tube was removed after cholangiography followed by removal of the drain on the next day. The actual success rate for group B was 101 of 126 patients (80.2%).

The overall success rate in both groups was similar (88.1% in group A vs. 80.2% in group B; P = 0.20). However, the average number of procedures per patient was significantly lower in group A than in group B (1.1 vs. 2.23; P < 0.001) (Table 3).

The mean operative time in group A was significantly shorter than that in group B (71.8 ± 28.1 vs. 136.2 ± 37.3 min) (P < 0.001).

The overall complication rates between the two groups were comparable (28.6% in group A vs. 20.6% in group B; P = 0.6). Superficial surgical site infection was present in 7.1% of patients in both groups. Bile leak complicated the postoperative course in 16.7% of group A patients compared with 2.4% of group B patients (P = 0.002). However, this was transient in all patients and did not require any further intervention, although it prolonged the hospital stay. Uncontrollable operative bleeding occurred in two patients in group A and in three patients in group B, which required conversion to open surgery (Table 4).

During the first 24 h after surgery, the pain score was lower in group A than in group B (5.3 ± 2.1 vs. 6.2 ± 2.3; P = 0.03). The hospital stay for patients of group A was significantly shorter compared with group B (4.5 ± 2.1 vs. 5.4 ± 6.3 days; P = 0.03). The average cost for the treatment per patient in group A was $5479.5, which was significantly lower than that in group B ($8219.2) (P = 0.001). Patient satisfaction score was measured on a verbal rating scale of 0–3 at 1 month after surgery. Patients in group A had higher satisfaction scores compared with patients in group B (2.31 ± 0.4 vs. 1.87 ± 0.9; P = 0.006) (Table 5).

All of the patients were scheduled for postoperative follow-up at 1 week, 1, 6 months, and up to 1 year or at any time if symptoms developed.

Discussion

The management of CBD stones has gone through various stages of development and innovation, and LCBDE is now considered a better procedure compared with endoscopic extraction of stones, with comparable morbidity and mortality and a shorter hospital stay in fit patients [21]. Although ERCP is effective and safe, this management option has several disadvantages, including a large number of normal ERCP's performed, up to 86% when ERCP is performed routinely for all patients and division of the choledochal sphincter in young adults, leading to loss of the normal physiologic barrier, with long-term complications such as ampullary stenosis, duodenobiliary reflux, and recurrent stone formation [8].

Only a few randomized controlled trials have compared single-stage and two-stage management with preoperative ERCP [814]. Previous studies randomized patients with suspicion of choledocholithiasis based on biochemical and ultrasound parameters. However, as seen in previous literature, this leads to an unacceptably high rate of negative interventions [2223]. In the current study, we routinely performed a preoperative MRCP for all patients to confirm the diagnosis of choledocholithiasis and avoid negative interventions.

In our study, we used the transcystic approach using the Dormia basket. Transcystic exploration of the CBD has the advantage of avoiding a choledochotomy; in earlier studies, the CBD explorations were performed using the transcystic approach [24252627]. In contrast, the majority of CBD explorations in different studies involved direct choledochotomy rather than transcystic exploration of the CBD [28293031]. This could be due to the larger size of the CBD stones in their studies, and it was not feasible to achieve complete clearance of the CBD with transcystic exploration, or the CBD stones were present in the supracystic portion of the CBD, which would have been difficult to remove through the transcystic route.

The success rate for LCBDE in our study was 88.1%, which was comparable to that reported in the existing literature (80–98.5%) [32333435]. The study also showed similar success rates for the single-stage and two-stage procedures (88.1 vs. 80.2%), but the single-stage procedure was better in terms of a shorter hospital stay, higher patient satisfaction, and better cost-effectiveness compared with two-stage management.

Rabago et al.[36] reported a success rate of 88.2% for intraoperative ERCP, and Ibrarullah [37] reported a success rate of 87% for single-sitting LC and intraoperative ERCP. The success rate decreased to 79% when the stones were large and impacted, which was a major risk factor for failure of mechanical lithotripsy. The current study found ERCP to have a success rate of 80.2%. The main reason for unsuccessful clearance was impacted stones and difficulty with cannulation.

LC after ERCP is known to be difficult, with a higher complication rate [3839], due to the inflammation and fibrosis in and around Calot's triangle after ERCP. Allen and Leeth [38] and Donkervoort et al. [39] reported greater difficulty and higher conversion rates with cholecystectomy after ERCP and the possibility of unpredictable adhesions. Furthermore, Nair et al.[40] showed that the presence of a stent greatly increased the difficulty and the conversion rate for LC. Our study reported that five patients in group B were converted from LC to open cholecystectomy following successful ERCP due to adhesions and uncontrollable bleeding; other nine patients were converted to open cholecystectomy after failed ERCP.

Cost-effectiveness in healthcare is increasingly becoming one of the criteria influencing the choice of patients and healthcare providers. Factors such as operative time, hospital stay, number of procedures, and rate of complications influence overall costs, and any increase in these parameters adds considerably to the cost of treatment. Topal et al.[41] and Urbach et al.[42] have found the average costs for the single-stage approach to be significantly less than that for ERCP followed by LC. However, these two studies were nonrandomized, analyzing only patients with an uncomplicated postprocedural course. Rogers et al.[43] in their randomized trial comparing single-stage and two-stage procedures performed a cost analysis and found similar results. We also found that the overall costs were significantly lower for the one-stage procedure than for the two-stage procedure.

The mean operative time was shorter in group A than in group B in our study. This was expected as we added the operative time of ERCP to the operative time of LC in group B. Increased operative time in the two-stage management would lead to higher morbidity, especially for high-risk patients, thereby increasing the hospital stay and the overall cost of treatment. Noble et al.[44] randomized 91 high-risk patients with a median age of 74.56 years and concluded that approaches to ductal clearance did not differ in terms of postoperative stay, complications, or conversions in high-risk patients. The mean age of our study population was 44.5 years. Martin et al.[45] conducted a meta-analysis of studies comparing preoperative ERCP and LC with LCBD exploration and found significantly shorter hospital stays in the surgical arm. The mean hospital stay in our study was shorter in group A than in group B.

The mean number of procedures in group A was significantly fewer compared with group B, and this was a drawback of the two-stage procedure. Compliance of the patients also was an issue, with many patients having to be reminded repeatedly to follow-up for cholecystectomy as clearance of CBD stones relieved them of symptoms.

The complication rates in the literature have not differed significantly between the two strategies. A meta-analysis found the morbidity rates to be 19% in the single-stage group and 15.2% in the two-stage group, and the difference was not statistically significant [46]. Our study also showed similar results (28.6 vs. 20.6%; P = 0.6). In the current study, the higher rate for bile leak in group A was transient and we did not observe any significant bile leak requiring any intervention in these patients at follow-up evaluation.

Conclusion

Although both treatment methods have equivalent success rates, the one-stage management is better in terms of shorter hospital stay, fewer procedures, and better overall satisfaction and cost-effectiveness compared with the two-stage approach. In addition, the one-stage management also avoided the risks associated with ERCP and sphincterotomy and kept the sphincter of Oddi intact, and this was associated with a lower risk for late CBD stone formation. Hence, the outcomes of this study suggest that the one-stage management is the treatment of choice for patients with concomitant GB and CBD stones, especially in younger patients who have longer period of risk for recurrence of CBD stones.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflict of interest.

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