patients
In this retrospective study, we collected and analyzed the data of patients with large CBD stones (≥15mm) from April 1, 2017 to June 30, 2021. The incidence of stone recurrence was determined via calls. We defined inclusion criteria as follow: 1. Maximum CBD stone diameter ≥ 15 mm. 2. ERCP performed initially on the patient. 3. Balloon dilation diameter ≥ 12 mm. Exclusion criteria: 1. Gastrointestinal reconstruction. 2. Liver transplantation. 3. Severe abnormal coagulation. 4. Need for anticoagulant drugs within 7 days (Aspirin, Rivaroxaban and others). 5. Acute pancreatitis before the ERCP. 6. Age< 18 years. 7. Hospital stay < 48 hours.
Endoscopic procedure:
ERCP was performed with a side-viewing duodenoscope (JF260V/240V, Olympus, Tokyo, Japan). Propofol was used for anesthesia. Duodenoscope was advanced into the descending portion of the duodenum and the papilla was cannulated. A 0.035-inch guidewire (Olympus, Tokyo, Japan) was inserted into the CBD cannulation, followed by the injection of 20mL loversol into the bile duct and a cholangiogram was obtained.
In the EPLBD group of patients, a large dilation balloon was advanced over the guidewire and positioned. The balloon was inflated gradually until the waist disappeared at 2.0-6.0 atm of balloon pressure and approximately 30-120 s of dilation time. In the ESLBD group of patients, the EST was performed first to cut the ampullary sphincter. The incision was performed in the direction of 11 to 12 o’clock, followed by EPLBD. A wire basket was used to remove the stone. Lithotripsy was used to crush stones if they could not be removed with EPLBD or ESLBD. After stone removal, cholangiogram was obtained again to confirm the clearance of CBD stones. A successful stone removal procedure was defined by no residual stones or need for further ERCP. A nasobiliary drainage or stent was used in every patient, along with antibiotic treatment after ERCP.
Endpoints
Primary outcomes included success rates of stone clearance, complications associated with ERCP (pancreatitis, hemorrhage and infection), the use of lithotripsy, recovery time, hospital stay and total costs of hospitalization. Secondary outcomes were risk factors for stone recurrence.
Definitions
Procedure time: The time starting from successful cannulation of the bile duct up to nasobiliary insertion.
Postoperative recovery time: The time from the completion of ERCP until patient discharge. If ERCP was performed more than once, the recovery time was calculated from the completion of the last ERCP.
Pancreatitis: Patients with abdominal pain accompanied by serum lipase or amylase, which was more than three times the upper limit of normal after more than 24 h after post-ERCP. Pancreatitis was graded using the modified Cotton standard[9, 10].
Infection: The criteria for infection were: 1. Positive test results of bile, blood or sputum microbiological culture. 2. Fever (>38℃) or abdominal pain accompanied by significant increase in white blood cells (≥12×109).
Hemorrhage: Bleeding during the procedure or a 20% decreased in hemoglobin level.
Statistical analysis
Data were analyzed with SPSS26.0 for windows (Armonk, NY, IBM Corp). Continuous variables were expressed as medians and interquartile ranges [M (P25, P75)] and data were compared using Mann-Whitney-U test. Categorical variables were expressed as numbers. Percentages [n (%)] and data were compared via c2 test or Fisher’s exact test. The risk factors for stone recurrence were analyzed via multiple logistic regression. The stone recurrence in both groups was compared via Kaplan-Meier (Log-Rank test). A two-sided P value of less than 0.05 was considered statistically significant.