Single Stage Management of Concomitant Cholelithiasis and Choledocholithiasis

Introduction: Concomitant cholelithiasis and choledocholithiasis are commonly managed in two stage procedure, endoscopic management of common bile duct stone followed by laparoscopic cholecystectomy in different time and setting. We perform these two procedures in same sitting in operating room set up. We evaluated the procedure in terms of outcome, feasibility and complications. Methods: Prospective cross-sectional study carried out since April 2013 to August 2016 in all patients who had undergone single stage endoscopic and laparoscopic management of concomitant cholelithiasis and choledocholithiasis. Patient’s demography, procedural time for different procedure and procedure in total and post-operative complications were recorded and analyzed with suitable statistical methods. Results: Out of 50 cases enrolled, 2 patients were converted to open. Out of 48 patients, 3 needed re-attempt for completion. Majority were female 36 (72%), mean age was 39.48years. Mean common bile duct diameter and mean stone size was 11.43±2.63 cm and 7.99±2.01cm, respectively. Mean of total procedural time was 90.93± 33.68 minutes. In most of the cases, laparoscopic cholecystectomy performed first followed by endoscopic method (66.7%). Total procedural time was less in the patients who underwent laparoscopy first in comparison to endoscopy first. Clinically significant complications like cholangitis, pancreatitis and duodenal perforation occurred in 7 patients. Out of 4 patients who developed pancreatitis, one had severe acute pancreatitis requiring prolonged hospitalization. Conclusion: Single stage management of common bile duct and gall bladder stone by laparoscopic and endoscopic method is feasible in our setup with acceptable results. Endoscopic treatment of common bile duct stone if performed first, is associated with longer procedural time. _______________________________________________________________________________________


INTRODUCTION
Incidence of concomitant cholelithiasis and choledocholithiasis is about 10%-20%, the management of which is controversial. 1 Pre-operative Endoscopic Retrograde Cholangiopancreatography (ERCP) followed by Laparoscopic cholecystectomy (LC) is the most common strategy since 1990, worldwide. 2 It is a two stage procedure associated with some organizational and technical problems as it is done by different team at different time. 3 In our center, ERCP is performed by surgeons in operating room (OR) set up. So, we combine LC with ERCP in the same sitting with same general anesthesia to deal concomitant CBD stone at once.
In this study, we have tried to see the feasibility and outcome of the procedure in our setup.

METHODS
This is a prospective cross-sectional study, carried out in the department of surgery, Kathmandu Medical College since April 2013 till Aug 2016. The ethical approval was taken from IRC-KMC. The patients who were diagnosed as having gall bladder stone as well as common bile duct stones were given the options for different modality of management available in our unit like, single stage open surgery, single stage laparoscopic surgery, two stage ERCP and LC and single stage LC and ERCP. Those who were treated with laparoscopic cholecystectomy(LC) and endoscopic retrograde cholangiography (ERCP), endoscopic sphincterotomy (ES) and stone extraction in the same sitting are included in the study.
After taking informed consent, required patient's investigation were sent. Complete blood count (CBC), coagulation profile, grouping, renal function test (RFT), Liver function Test (LFT), Viral profile for hepatitis C, hepatitis B and Human immunodeficiency(HIV), Chest X-ray(CXR), Electrocardiogram (ECG) were done routinely in every patient. Initial mode of diagnosis of choledocholithiasis is Ultrasonogram (USG) at least done in our institute. Additional investigation like Echocardiogram (ECHO), Pulmonary function test (PFT), Magnetic Resonance Cholangio-pancreatogram (MRCP) and Computed Tomography (CT) were done according to the indication of the patient's disease and co-morbidities.
All patients received General anaesthesia. They were intubated with flexo-metallic tube. Some cases underwent LC first approach. In them, LC was performed in supine position, all with 3 ports. After the ports were closed, patient were turned to semi-prone position and ERCP, Endoscopic Sphincterotomy (ES) was performed and stones were extracted. Stone clearance was checked with completion cholangiogram at the end of the procedure in all cases. Those cases who underwent ERCP first approach, after completing the endoscopic procedure in semi-prone, they were turned up and LC performed with 3 ports.
At the end of endoscopic procedure, stenting of CBD with appropriate sized plastic stent was done selectively according to the surgeon's choice. Patients demographics, pre-operative findings, ERCP time (duration from insertion of duodenoscope to extraction of stones), LC time (duration from skin incision to skin closure) , total operating time (duration from the time of intubation to extubation), difficulties during procedures, complications, need of repeat ERCP and hospital stay period were recorded. Serum amylase was evaluated at 24hours and USG was performed before discharge to evaluate post-operative effects.

RESULTS
During this period, 50 cases were attempted. Majority were females 36 (72%) and 14 (28%) were male. Size of common bile duct and stones as reported in USG. Duration for different events in operative procedures for single stage management of concomitant CBD stones and cholelithiasis as well as postoperative amylase in day1 (Table 1). Complications ware observed in 7 cases. All of them were managed conservatively and successfully ( Table  2). Duodenal perforation was suspected in one case when small amount of contrast extravasation was seen. Probably a small puncture was occurred in retroperitoneal portion of duodenum during ERCP needle knife sphincterotomy. The procedure was abandoned and patient was managed conservatively. The patient's condition was quite stable with no features of peritonitis and sepsis. She was started on oral feeds in second day. As the condition was stable, next attempt was done after four days, papilla was open due to previous needle knife sphincterotomy, so easy cannulation and stone extraction was successful. Three cases developed cholangitis, two of them had tiny liver abscesses as well, which were managed with conservative treatment.

Joshi et al. Single Stage Management of Concomitant Cholelithiasis and Choledocholithiasis
Retained stones were observed in 7 cases during postoperative USG. Only, four of them needed subsequent ERCP, three in our center and one in center outside, whereas three of them were free of stone after followup in one week. In last 30 years, there has been a major development in the management of gall stone related diseases. There has been wide availability of ERCP as routine procedure and laparoscopic cholecystectomy has replaced open approach as well as use of laparoscopic exploration of common bile duct (LCBDE) as per the need. Single stage LCBDE is an alternative approach and LCBDE has been found to be superior to open surgery in terms of efficiency, morbidity and mortality. Along with it, new imaging techniques such as magnetic resonance cholangiography (MRC) and endoscopic ultrasound (EUS) are being used to accurately visualize the biliary system without instrumentation of the ducts. 2,13,14 Initially, when CBD exploration was performed by laparotomy, prospective randomized trials did not show the superiority of pre-operative endoscopic techniques over open CBD surgery for stones. 15,16 With the rapid popularity of laparoscopic cholecystectomy, there was growing interest of laparoscopic common bile duct exploration, indeed. Because of an obvious lack of expertise in laparoscopic surgery, surgeons elected to detect and treat CBD stones pre-operatively by ERCP and ES since, they considered LCBDE as an unduly, complex, and demanding procedure. But the endoscopic approach requires several sessions of anesthesia and cumulates the risk of ES and LC along with the increased operative cost. 17,18 Concomitant LC and LCBDE, whether transcystic or transcholedochal is an excellent option of single strategy associated with additional benefits of cost and hospital stay but the acceptance is far off due to steep learning curve and the meta-analysis is unable to show significant difference in clinical outcome in comparison to ES followed by LC group. [19][20][21][22] The reported incidence of CBD stones found during laparoscopic cholecystectomy ranges from 3-10%. 23,24 It is unclear whether an asymptomatic choledocholithiasis requires treatment. Furthermore, it is well established that small stones may pass through the ampulla of Vater spontaneously. 25 Moreover, it is not clear what stone size precludes trans-papillary migration in to the duodenum and no any criteria to predict and recommend the treatment method to treat CBD stone whenever detected. 26 With the development of laparoscopic and endoscopic techniques, many alternative treatments options are available for concomitant cholelithiasis and choledocholithiasis. This has been observed in the study from Sweden reporting a 'paradigm shift' from open choledochotomy and cholecystectomy toward bile duct clearance using the endoscopic route and selective laparoscopic cholecystectomy in patients with concomitant cholelithiasis and choledocholithiasis. 27 ERCP is preferred approach in most centers for management of CBD stones however it is associated with pertinent complications like pancreatitis, hemorrhage, cholangitis, duodenal perforation and mortality. 7 Failure of ERCP is mentioned to be around 5-10%. 4 We also observed the similar experience in our series, two patients needed to be converted to open, three needed two sittings to complete the procedure and other four needed re-ERCP, three in our center and one in other center for retained stone. There were complications including cholangitis and pancreatitis including liver abscess and severe acute pancreatitis ( Table 2). All of these problems were related to endoscopic procedure. It is probably because the procedure inherits the complication and being surgeons we have less experience in endoscopic technique in comparisons to laparoscopic surgery as well.
Timing of LC following the ERCP is another issue. The early laparoscopic cholecystectomy after ERCP and ES for concomitant cholelithiasis and choledocholithiasis in observational and randomized studies have found to have better outcome if performed within 72 hours in comparison to delayed approach. The reasons given to this benefits are cost of repeated hospital admission, passage of another gallstone into the common bile duct during the waiting periods, and the ERCP induced peri-choledochal inflammation causing subsequent laparoscopic cholecystectomy more difficult. 3,[27][28][29][30] If these are the reasons, "same sitting policy" , which we do, is definitely more better than the "same hospital admission policy". Various ways of "same sitting policy" have been observed like complete laparoscopic approach, endoscopic and laparoscopic approach and Rendezvous technique (helping laparoscopic method to cannulate CBD for endoscopic clearance). Various studies performed with the comparisons between two procedures, ERCP followed by laparoscopic cholecystectomy with same sitting laparoscopic CBD exploration has shown no significant difference but cost effective associated with shorter hospital stay in single stage technique. 21 Laparoscopic cholecystectomy with endoscopic treatment of CBD stones are although two procedures but are performed in various combinations together like preoperative ERCP followed by laparoscopic cholecystectomy, Laparoscopic cholecystectomy followed by ERCP, intraoperative ERCP and laparoscopic cholecystectomy.
Laparoscopic cholecystectomy followed by ERCP creates problem with decision making if ERCP fails and requires open or laparoscopic procedures. The most favored method is ERCP followed by laparoscopic cholecystectomy worldwide. This is two step procedure mostly performed by separate group of clinicians, endoscopist and laparoscopic surgeon in separate setup in different time. 10 Basic purpose of our study is to evaluate the feasibility of single stage management of concomitant cholelithiasis and choledocholithiasis. Theoretically, if both the procedures can be performed in single sitting, it saves time, money and physical exhaustion to the patients specially in the country like ours where people come from remote areas to the cities to seek medical care for these problems.
In our center, author (MRJ) as being laparoscopic surgeon, also performs ERCP in operating room using C-arm instead of fluoroscopy. So, the two procedures, laparoscopic cholecystectomy and on table ERCP and ES are combined and performed by the same surgeon or group of surgeons. Whether to perform ERCP first or laparoscopic cholecystectomy first was matter of debate initially. ERCP first approach is theoretically better approach because if ERCP fails, LC and LCBDE can be performed changing the patients position in the same sitting. But this procedure created some problems in our experience. After ERCP, there was bowel insufflation and distension impairing the visibility of Calot's triangle while performing LC specially when ERCP took long time. In one occasion, we had to convert to open procedure and this too was difficult due to excessive bowel distension. Then we started to perform LC first and majority of the cases were performed by LC first approach. In table 3 we compared the two approaches and has found strong benefit of LC first method in relation to time taken to complete the LC as well as total operating time. This reflects the procedural difficulty when ERCP done first. To avoid this problem, early abandonment of ERCP and switching over to LCBDE before excessive bowel distension could be done. We think there is a need of formal large scale comparative study to address this issue. We also compared the dilatation of CBD with ERCP cannulation time but did not find it as a determining factor for the easy cannulation (Table 3) contrary to common belief that cannulation is easier when the duct is dilated. 31

CONCLUSIONS
Performing ERCP and ES in the same sitting with laparoscopic cholecystectomy is possible, safe and beneficial in our setup provided the surgeons perform ERCP themselves or the ERCP team available in OR. Whether to perform ERCP first or laparoscopic cholecystectomy first requires further comparative study as both the procedures have advantages and disadvantages on either side. Having the complete armamentarium starting from open approach to minimally invasive approach like ERCP and laparoscopic common bile duct exploration in operating room helps to select the right procedure for the individual patients with unique problems in the same sitting as a complete package for the management of common bile duct stone. In case of failure, switching over to another suitable procedure ensures the maximum benefit to the patient in the same sitting, provided the safety of patient is taken care as a prime importance.