METHODS: A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied.
RESULTS: A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes.
CONCLUSION: Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.).
AIMS: The aims of this study were to determine the efficacy of rectal diclofenac in preventing PEP and to evaluate any adverse events.
METHODS: This was a randomized, open-label, two-arm, prospective clinical trial. Only patients at high risk of developing PEP were recruited. They received 100 mg rectal diclofenac or no intervention immediately after ERCP. The patients were reviewed 30 days after discharge to evaluate any adverse event.
RESULTS: Among 144 recruited patients, 69 (47.9%) received diclofenac and 75 (52.1%) had no intervention. Eleven patients (7.6%) developed PEP, in which seven were from the diclofenac group and four were in the control group. Eight cases of PEP (5.5%) were mild and three cases (2.1%) were moderate. The differences in pancreatitis incidence and severity between both groups were not statistically significant. There were 11 adverse events reported. Clinically significant bleeding happened in four patients (2.8%): one from the diclofenac group and three from the control group. Other events included cholangitis: two patients (2.9%) from the diclofenac group and four (5.3%) from the control group. One patient from the diclofenac group (1.4%) had a perforation which was treated conservatively.
CONCLUSIONS: In summary, prophylactic rectal diclofenac did not significantly decrease the incidence of PEP among patients at high risk for developing PEP. However, the administration of diclofenac was fairly safe with few clinical adverse events.
METHODS: Patients with mild to moderate ABP were prospectively randomized to either an early cholecystectomy versus a delayed cholecystectomy group. Recurrent biliary events, peri-operative complications, conversion rate, length of surgery and total hospital length of stay between the two groups were evaluated.
RESULTS: A total of 72 patients were enrolled at a single public hospital. Of them, 38 were randomized to the early group and 34 patients to the delayed group. There were no differences regarding peri-operative complications (7.78% vs 11.76%; p = 0.700), conversion rate to open surgery (10.53% vs 11.76%; p = 1.000) and duration of surgery performed (80 vs 85 minutes, p = 0.752). Nevertheless, a greater rate of recurrent biliary events was found in the delayed group (44.12% vs 0%; p ≤ 0.0001) and the hospital length of stay was longer in the delayed group (9 vs 8 days, p = 0.002).
CONCLUSION: In mild to moderate ABP, early laparoscopic cholecystectomy reduces the risk of recurrent biliary events without an increase in operative difficulty or perioperative morbidity.