Study Design and Location
The prospective study was conducted at the Gastrointestinal Endoscopy Unit of Obafemi Awolowo University Teaching Hospital Complex, Ile Ife, from February 2018 to April 2023. The unit received referrals of patients with biliary injury post cholecystectomy from all over Nigeria and Ghana. The institution has facilities for both ERCP and open surgery.
Sample size and Sampling Technique
All consecutive cases referred to the unit for ERCP and therapeutic endoscopic interventions post cholecystectomy within the reference period formed the subjects of the study. Patients who had bile leaks post-liver surgery were excluded from the study.
Data Collection
Data was collected using a standard proforma designed for the study. Data collected included demographic characteristics and previous hospitalization due to biliary pathology, time of surgery and presentation, last treatment before presenting, clinical presentation, site of the leak and associated conditions on ERCP, the various therapeutic endoscopic interventions, the one-month post-procedure outcome and complications related to these interventions were collated.
Before the ERCP, all patients had undergone preliminary investigations like hemogram, PT/PTT, INR, liver function tests, renal function tests, blood glucose levels, serology for HIV, Hepatitis C and B, and ultrasonography of the abdomen. Most patients also had an abdominal CT scan and MRCP before the procedure. Routinely, electrolyte and clotting factor derangement were corrected before the procedure. As indicated, the clotting factor derangement was updated using Vitamin K and fresh frozen plasma. Those that had peritonitis from bile leak at presentation were managed with peritoneal washout and drain insertion at laparotomy to control the leak before ERCP.
The clinical details and imaging features were reviewed at multidisciplinary meetings to assess the appropriateness of the referral and the pre-operative diagnosis. The multidisciplinary meeting comprised endoscopists, radiologists, anesthesiologists, nurses, and their trainees.
ERCP was performed under general anesthesia with cuffed endotracheal intubation administered with most of the patients placed in a prone position except when patients’ conditions did not allow for such. In that case, the procedure was performed supine. The procedures were performed using the Evis Exera II Video duodenoscope TjfQ180V. Carm was used for real-time fluoroscopic visualization of the biliary tree after injection of contrast agent into the biliary tree. The contrast agent used was ScanluxR 370 mg/ml, which contains 755 mg/ml of Iopamidol as the active substance. This was diluted with normal saline in equal proportions before the injection.
Selective cannulation of the CBD was attempted using standard sphincterotome and hydrophilic guidewire (Boston Scientific Corp., Natick, MA, USA). If initial attempts at cannulation were unsuccessful, cannulation was tried using an ERCP cannula. Precut was performed using a needle knife to facilitate access to the biliary tree if the previous effort failed. Cholangiography was used to assess for evidence of biliary tree abnormality, such as extravasation of bile to suggest biliary leak, biliary stricture, or filling defect to suggest retained stone (Fig. 1). For those with bile leak, sphincterotomy and a removable plastic biliary stent (7Fr or 10Fr by 9cm or 7cm) or fully covered self-expanding metal stent were inserted to allow anterograde drainage. The location of the lesion and availability of the stent generally guide the length of the stent. Any other abnormal findings at ERCP (e.g., retained stones) were treated as required. The abdominal external drains inserted at laparotomy for patients with bile leaks were removed as soon as the drain became inactive following ERCP. Patients with incomplete stricture had the following procedure, which included insertion of a plastic stent or metal stent and dilatation of the stricture using a hurricane balloon. ERCP was repeated within six weeks to 3 months after the resolution of the biliary leak. Cholangiography was used to confirm the healing of the biliary fistula and the absence of a biliary stricture or other pathology such as choledocholithiasis. All the patients who had complete stricture of the biliary tree had surgery – Roux-en-Y hepaticojejunostomy. Percutaneous biliary drainage (PTBD) was used for those unsuitable for surgery. Because most of the patients were referred from other institutions, they were all sent back to their primary institutions after the completion of treatment. However, our research staff followed up with the patient on the phone for one month after the procedure. The criteria used to determine the resolution of complications include clinical features with normalization of liver function tests, cessation of external drain output (when present), and resolution of intraabdominal collection on follow-up ultrasound with no further complications.
Data were analyzed using the IBM SPSS Statistics for Windows, version 22.0 Armonk, NY: IBM Corp. Categorical variables were presented as frequencies and percentages. The data were presented in tables and charts. Continuous variables such as age and the duration of symptoms were presented as median and range. ERCP and fluoroscopic images were also preserved to demonstrate findings from the procedure further. Presenting complaints were classified into four categories – recurrent ascending cholangitis, peritonitis, persistent bile fistula, and jaundice. Patients presenting with recurrent ascending cholangitis were those that presented with a constellation of recurring symptoms such as upper abdominal pain, fever with chills and rigor, and intermittent jaundice. These patients had been admitted multiple times before referral and were placed on antibiotics each time they had symptoms. Patients classified as having peritonitis were those that have uncontrol bile leak leading to bilious peritonitis at presentation. Patient who had peritonitis had abdominal pain, abdominal distension, bile leak from the wound, etc. All these patients had laparotomy and peritoneal lavage, as well as insertion of an abdominal external drain(s) to control the leak before performing ERCP. ERCP was performed electively in all clinically stable patients, usually within five days of the surgical intervention. Patients with persistent fistula are those that had bile duct injury at the referring hospital and subsequently had open or laparoscopic peritoneal lavage and insertion of abdominal drain to control the bile leak. Two patients who had open cholecystectomy and common bile duct exploration with insertion of T-tubes complicated by biliary fistula were categorized as having persistent biliary fistula. Patients with Jaundice were those who developed jaundice after cholecystectomy with no significant fever or upper abdominal pain. These patients had elevated serum bilirubin and deranged liver enzymes following cholecystectomy.
Ethical Consideration
This study was approved by the Ethics and Research Review Board of Obafemi Awolowo University Teaching Hospitals Complex (protocol number ERC/2019/01/08). All participants signed an informed consent as approved by the board.