From October 2015 to October 2017, 1504 patients underwent ERCP in National Taiwan University Hospital, and successful cannulation was achieved in 1408 patients. Among them, two patients underwent double-guidewire method. Eighteen patients with deep CBD cannulation failure received percutaneous transhepatic cholangial drainage or operation (Figure 1). Among 78 patients included for analyses, 31 patients received TPS and 47 ones received NKF (Table 1). All cases of subject were with naive papilla. The mean age was 69.6 years old. The major indications of ERCPs included 38 patients (48.7%) of bile duct stone, and 27 patients (34.7%) of malignant bile duct obstruction. Overall success rate of deep cannulation was 79.5% (62 patients). 5 (6.4%) patients complicated with bleeding, 8 (10.3%) patient had post-ERCP pancreatitis and 3 (2.6%) patients had post-ERCP cholangitis. None of them had perforation.
Table 2 presented the characteristics of the TPS and NKF group. Patients in TPS group had more pancreatic duct cannulation, compared with patients in NKF group. More than half of patients (16/31) received three to six times of pancreatic duct cannulation during ERCP. 23 (74.2%) patients in TPS group had successful bile duct cannulation, while 39 (83.0%) patients in NKF group access bile duct successfully.There was no significant difference regarding the bile duct cannulation rate between two groups (p = 0.34). Moreover, three patients achieved successful bile duct cannulation after NKF, though encountering failure during TPS in the beginning. These three patients were not counted as successful bile duct cannulation.
For the prophylaxis of PEP, four (12.9%) patients in TPS group and six (12.8%) patients in NKF group received prophylactic pancreatic stenting. Significantly more patients (twelve, 38.7%) in TPS group received continuous gabexate mesilate infusion after ERCP, comparing with five (10.6%) patients in NKF group. Five (16.1%) patients in TPS group and three (6.4%) patients in NKF group received combination of gabexate mesilate infusion and diclofenac rectal suppository. Two (4.26%) patients in NKF group received diclofenac sodium rectally for PEP prophylatic treatment. More patients in NKF group received no PEP prophylaxis than in TPS group (72.3% vs. 41.9%, respectively, p = 0.007).
Table 3. summarized the adverse events after ERCP. The overall adverse events after ERCP were similar in both groups (TPS vs. NKF, 19.3% vs. 19.1%, respectively, p = 0.99). There were no significant difference between TPS and NKF group in post-ERCP bleeding, acute cholangitis and perforation (19.3% vs. 12.8%, 0% vs. 4.3%, 0% vs 0%, respectively). Patients in TPS group had higher Post-ERCP amylase level than patients in NKF group (median level: 155 U/L vs. 62U/L, respectively, p = 0.01). Five (16.1%) patients in TPS group developed PEP, while three (6.4%) patients in NKF group had PEP (p = 0.17). All patients had PEP were mild in severity, and the details of the PEP patients was summarized in table 4.
Since both groups had similar adverse events after ERCP, we tried to investigate the factors associated with PEP. Univariate analysis (Table 5.) showed that younger than 65-year-old diclofenac sodium +/- gabexate mesilate treatment after ERCP are statistically significant patient-related risk factors associated with occurrence of PEP. Independent risk factors for PEP were assessed by multiple logistic regression and it showed age younger than 65 years old (p = 0.03, OR = 0.11) and EPBD (p = 0.011, OR = 20.35) were independent risk factors for PEP.