Same Anesthesia Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy: The Pediatric ERCP Database Intiative Experience

Abstract

Background: 

Successful combined Laparoscopic cholecystectomy and endoscopic retrograde cholangiopancreatography (ERCP) in the Same Session (LESS) has been reported in several studies in adult patients with choledocholithiasis.

Methods: 

This was a retrospective analysis of data collected prospectively in the Pediatric ERCP Database Initiative using REDCAP. Adverse events were recorded separately and were reviewed for this study. The primary outcome was the hospitalization days. Secondary outcomes included total duration of anesthesia, morbidity, time from diagnosis to procedure.

Results: 

Twenty-five patients underwent LESS, and 42 underwent the traditional ERCP followed by laparoscopic cholecystectomy. The groups were similar in age, weight, ASA. The median length of stay in the LESS group was 3 days, compared with 4 days (P = .32). Total procedure time was similar between the 2 groups, but anesthesia time was shorter in the LESS group (P = .0401). Morbidity was similarly low between the 2 groups.

Conclusions: 

Relative to 2 interventions, a single session combining ERCP and laparoscopic cholecystectomy in pediatric patients is effective with a similar adverse event rate and length of stay. The use of a single sedation and reduced total anesthesia time are potential benefits of this approach. This modality may be considered for pediatric patients with choledocholithiasis with or without hemolytic disease.

An increase in morbid gallbladder disease in pediatric patients has led to an increase in cholecystectomies performed in this population ⁽¹⁾. Concomitant usage of endoscopic retrograde cholangiopancreatography (ERCP) for these patients has also increased, with up to 30% of patients presenting with biliary or pancreatic obstruction, nearly 2-fold that of adults. Since 2014, the Pediatric ERCP Database Initiative (PEDI), a prospective international database has collected longitudinal data on patients undergoing ERCP in pediatric patients. Specific sub-studies are ongoing including the evaluation and management of patients with suspected choledocholithiasis.

In both pediatric and adult patients, ERCP and laparoscopic cholecystectomy are typically performed on different days under 2 separate anesthetics. Successful combined ERCP and same session laparoscopic cholecystectomy has been reported in several studies in adult patients with choledocholithiasis ^(2–8). Combined procedures have been performed in children, typically to limit anesthetic exposure in patients with complicated sickle cell disease or other complex medical problems. The aim of this work is to evaluate the utilization of the combined technique and compare efficacy to the traditional method (each procedure performed on a separate day). We hypothesized that laparoscopic cholecystectomy and ERCP in the same session (LESS) procedures would have shorter hospital stays, similar procedure times, and no difference in adverse events.

METHODS

Patient Population

This retrospective study was a sub-analysis, and utilized data from the PEDI database. Prospective data from 67 consecutive ERCPs from May 2014 to December 2016 for the diagnoses of suspected choledocholithiasis and gallstone pancreatitis on children <19 years from 13 PEDI IRB-approved centers were entered into a REDCap (Research Electronic Data Capture, Vanderbilt University, Nashville, TN) database specific for pediatric ERCP (PEDI, Pediatric ERCP Database Initiative) ⁽⁹⁾. Informed consent was obtained as per the individual institution's IRB requirements. Only 4 of the 13 sites were part of the sub-study evaluating management of choledocholithiasis, and thus only data from these sites were analyzed, 3 of which performed LESS cases.

This study focused on patients who had both ERCP and laparoscopic cholecystectomy at the same admission. Inclusion criteria for this study included: patients less than 19 years of age with suspected choledocholithiasis with complete data entry for both ERCP and LC for the index admission. Exclusion criteria for this study included patients undergoing ERCP with acute pancreatitis or cholangitis or those with a prior intervention for choledocholithiasis (Appendix 1, Supplemental Digital Content, https://links.lww.com/MPG/B814).

Study Design

All data were collected prospectively and entered into the REDCAP database. Data elements included pre-procedure (basic demographic and clinical information), peri-procedural, and follow-up (2–4 weeks after the procedure). Specific peri-procedural data included: the diagnosis time, time to procedure from diagnosis, duration of procedures, and duration of anesthesia. Adverse events were recorded separately and were reviewed for this study. Procedure-related adverse events (AE) were systematically characterized utilizing the American Society of Gastrointestinal Endoscopy (ASGE) lexicon for AEs. Accordingly, a procedure-related AE was defined as any event that prevented completion of the planned procedure and/or resulted in admission to hospital, prolongation of existing hospital stay, another procedure, or subsequent medical consultation. Data capture within the PEDI database specifically queries for pancreatitis (typical pain, amylase or lipase greater than 3 times the upper limit of normal and/or related imaging findings), pain not related to pancreatitis, bleeding, cholangitis, fever without a source, and perforation for each ERCP performed with options to enter additional adverse events that are recognized ⁽¹⁰⁾.

Comparison groups were those managed with LESS and those managed by traditionally staged ERCP/LC approach. The primary outcome was the hospitalization days. Secondary outcomes included total duration of anesthesia, morbidity, time from diagnosis to procedure.

Study data were collected and managed using REDCap electronic data capture tools coordinated at UT Southwestern Medical Center.

Standard descriptive statistics were utilized to describe the population with means and inter-quartile ratios provided whenever appropriate. Variables were compared using 2-sided Fisher exact test for categorical variables and the Student t-test for continuous variables using IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp.

Technical Details of the Procedures

Endoscopic Procedure

All patients had general anesthesia with endotracheal intubation. Patients were placed in either the supine or prone position. Carbon dioxide was used for insufflation in all cases. A 12.1 mm diameter duodenoscope was used for cannulation, with a variety of papillotomes. Sphincterotomy was uniformly performed along with use of an extraction balloon. Radial or linear endoscopic ultrasound was utilized variably. Additional procedures, such as duodenal or gastric biopsy were performed if indicated. Sixty-six of 67 procedures were performed by pediatric gastroenterologists.

Surgical Procedure

A standard laparoscopic cholecystectomy was performed using 3 subcostal 5 mm ports and a 10 or 12 mm port at the umbilicus. All the cases were performed by pediatric surgeons laparoscopically and all patients received perioperative antibiotics.

RESULTS

A total of 25 patients underwent LESS, and 42 underwent the traditional ERCP followed by laparoscopic cholecystectomy. Patient demographics can be seen in Table 1. The groups were evenly matched with respect to sex, age, and race. LESS cases were performed at 3 of the 13 PEDI sites, with 22/25 (88%) cases performed at 1 institution (Texas Children's Hospital). Two patients having the combined procedure at one of the centers were previously published in a study by Gee et al ⁽¹¹⁾ from a single-center retrospective experience.

TABLE 1: Patient demographics

The duration of each procedure and total anesthesia times are presented in Tables 2 and 3. Patients who underwent LESS had a shorter duration of total anesthesia time, in part reflective of short ERCP times in the LESS group and a singular induction. Cholecystectomy times were not affected. The median length of stay in the LESS group was 3 days, compared with 4 days (P = 0.32). We also evaluated various time points from presentation to procedures and procedure to discharge. These are characterized in terms of the percentage of patients remaining who either waiting for a procedure or waiting for discharge (eg, presentation to first procedure, first procedure to discharge, and presentation to discharge). For example, in the LESS group, 48% of patients were discharged the day after their combined procedure, and 72% were discharged the subsequent day. The major laboratory parameters we assessed for obstruction were conjugated and total bilirubin. Both were similar between groups and suggest obstruction in both groups at time of procedures (Table 3). There was minimal morbidity in each group. Two patients in each group had repeat procedures for a retained stone 8% versus 5% (P = 0.63). No other minor or major adverse events were noted. Complete data from follow-up 2–4 weeks after the procedure was available for 60% of the LESS group and 57% of the traditional group (P = 1.0). There were no significant adverse events related to the procedures in either group noted at follow-up based on the ASGE lexicon ⁽¹⁰⁾.

TABLE 2: Hospitalization characteristics

TABLE 3: Procedural characteristics

DISCUSSION

Multiple options are available to manage the growing number of pediatric patients with morbid gall bladder disease. On the basis of recent data in children and adults, cholecystectomy during the same hospitalization is now recommended for patients with choledocholithiasis ^(12,13). A meta-analysis of 4 different management strategies for choledocholithiasis in adults demonstrated LC with intraoperative ERCP to be the safest and most effective option based on parameters, such as success rate, length of stay, and operative time ⁽¹⁴⁾. Although this strategy seems promising for children, there are thus far limited data in the pediatric population, as well as fundamental differences between the deliveries of pediatric ERCP compared with adults ⁽¹¹⁾. One such difference is that general anesthesia is almost always utilized for pediatric ERCP compared with a more variable use of deep sedation and general anesthesia in adults.

In this study, the outcomes for LESS were comparable with the traditional separate cholecystectomy and ERCP, and advocates for its use wherever appropriate. The increased time from presentation to the first procedure in the LESS group is likely accounted for by the coordination of a GI endoscopist, GI support staff, surgeon, and operating room availability. Significant findings in our study include the fact that patients undergoing combined ERCP and cholecystectomy under the same anesthetic had a decreased total anesthesia time. Future studies should address specific reasons for this; however, decreasing the number of inductions and emergences from anesthesia is an obvious benefit.

Common adverse events including pancreatitis, bleeding, and infection are well-established risks of ERCP in pediatric and adult patients. In our series, there were no significant adverse events in either group. Iqbal et al ⁽¹⁵⁾ reported post-ERCP pancreatitis rates in children of 2.5% and Troendle et al ⁽¹⁶⁾ reported rates of 5% focused on choledocholithiasis. Postprocedure, both groups had patients (n = 2) who required repeat care for suspected retained stones, which is similar to the adult experience ^(6,17). ERCP performed for choledocholithiasis in children is increasingly common and ERCP in children has been shown to be safe with a comparable risk to adults ⁽¹⁶⁾.

Concerns of gaseous distention of the small bowel following ERCP is likely unfounded as all cholecystectomies were completed laparoscopically. Carbon dioxide insufflation is now routinely used for advanced endoscopic procedures and appears to minimize abdominal distention. ERCP times were reasonably short, but the utilization of carbon dioxide is likely a major contributor to this as well. Before the PEDI database, however, we used air insufflation for ERCP in cases with no clear effect on surgical difficulty because of over-distention. In the LESS cases, we typically consider a reasonable ERCP time between 30 and 45 minutes after which we more closely assess the abdomen by imaging and/or direct examination.

No local or systemic infections were identified suggesting that a combined procedure does not appear to increase the risk of infection in children. We do recommend antibiotics for prophylaxis given the exposure of a clean-contaminated area to oropharyngeal bacteria from a highly disinfected endoscope. Infection rates were low in the adult comparative studies as well ⁽¹⁴⁾.

Although the initial patients selected for the combined procedure were patients with hemolytic disease, the practice has expanded to patients with comorbid disease, such as metabolic syndrome. One of the major restrictions to routinely performing LESS is the availability of physician resources as an available surgeon and biliary endoscopist are both needed as well as an available room to perform the procedure. Coordinating 2 physicians and available operating room time is likely reflected in the time from presentation to first procedure being slightly longer in the LESS group compared with the traditional group. At the 2 largest centers involved in this study, both have a high volume of pediatric ERCP and cholecystectomy, so the generalizability of this study may be limited to similar centers and related bias. The total hospitalization time in either LESS or traditional approaches are certainly dependent on physician availability, scheduling, acuity and operating room access.

The single-center experience by Gee et al ⁽¹¹⁾ included 2 of the LESS patients from 1 center, which overlap with this combined report. A single patient in the traditional group had a prolonged hospitalization because of an unrelated event, which serves as an outlier in the traditional group. The outlier was a 17 year-old with sickle cell disease who underwent an uneventful ERCP with stone removal on the day of presentation. The patient continued to have significant cholestasis and subsequently underwent an ultrasound-guided percutaneous liver biopsy (27 days after his initial ERCP), which was complicated by severe intraabdominal bleeding leading to multiorgan failure and a prolonged admission.

The major strength of this study is that data was collected prospectively as part of an international collaborative, allowing us to study a similar number of pediatric LESS cases as presented in the adult literature. Thus, this is the first multicenter study describing the utility of the combined procedures. One of the limitations of this study is that the majority of the LESS procedures occurred at 2 centers, potentially limiting the generalizability. Other combined procedures were done at other centers but not captured as part of the choledocholithiasis sub-study. The endoscopic and surgical approaches were also evaluated postanalysis for ongoing studies rather than a priori evaluation. All but 2 patients in the combined group had stones at endoscopy, an acceptable rate using a cut-off of 50% as suggested by the American Society of Gastrointestinal Endoscopy ^(18–20). This also suggests an augmented role for MRCP and/or endoscopic ultrasound as part of the combined procedure, although potentially adding more to the overall hospitalization.

A single session combining ERCP and laparoscopic cholecystectomy in pediatric patients is effective with a similar adverse event rate and length of stay compared with performing the procedures on separate days. The availability of a trained endoscopist, a surgeon, and operating room may impact the initial timing of procedures but have the potential to improve patient experience. This modality can be considered for pediatric patients with choledocholithiasis with or without hemolytic disease. Further work to optimize coordination of procedures and develop standardized protocols may improve the utilization of a combined approach.