AIM: To compare the new Olympus V-scope (VS) to conventional endoscopic retrograde cholangiopancreaticography (ERCP). METHODS:Forty-nine patients with previous endoscopic papillotomy who were admitted for interventional ERCP for one of several reasons were included in this single-centre, prospective randomized study. Consecutive patients were randomized to either the VS group or to the conventional ERCP group. ERCP-naïve patients who had not undergone papillotomy were excluded. The main study parameters were interventional examination time, X-ray time and dose, and premedication dose (all given below as the median, range) and were investigated in addition to each patient's clinical outcome and complications. Subjective scores to assess each procedure were also provided by the physicians and endoscopy assistants who carried out the procedures. A statistical analysis was carried out using the Wilcoxon rank-sum test. RESULTS:Twenty-five patients with 50 interventions were examined with the VS ERCP technique, and 24 patients with 47 interventions were examined using the conventional ERCP technique. There were no significant differences between the two groups regarding the age, sex, indications, degree of ERCP difficulty, or interventions performed. The main study parameters in the VS group showed a nonsignificant trend towards a shorter interventional examination time (29 min, 5-50 min vs 31 min, 7-90 min, P = 0.28), shorter X-ray time (5.8 min, 0.6-14.1 min vs 6.1 min, 1.6-18.8 min, P = 0.48), and lower X-ray dose (1351 cGy/m(2), 159-5039 cGy/m(2) vs 1296 cGy/m(2), 202.2-6421 cGy/m(2), P = 0.34). A nonsignificant trend towards fewer adverse events occurred in the VS group as compared with the conventional ERCP group (cholangitis: 12% vs 16%, P = 0.12; pain: 4% vs 12.5%, P = 0.33; post-ERCP pancreatitis: 4% vs 12.5%, P = 0.14). In addition, there were no statistically significant differences in assessment by the physicians and endoscopy assistants using subjective questionnaires. CONCLUSION:ERCP using the short-guidewire V-system did not significantly improve ERCP performance or patient outcomes, but it may reduce and simplify the ERCP procedure in difficult settings.
RCT Entities:
AIM: To compare the new Olympus V-scope (VS) to conventional endoscopic retrograde cholangiopancreaticography (ERCP). METHODS: Forty-nine patients with previous endoscopic papillotomy who were admitted for interventional ERCP for one of several reasons were included in this single-centre, prospective randomized study. Consecutive patients were randomized to either the VS group or to the conventional ERCP group. ERCP-naïve patients who had not undergone papillotomy were excluded. The main study parameters were interventional examination time, X-ray time and dose, and premedication dose (all given below as the median, range) and were investigated in addition to each patient's clinical outcome and complications. Subjective scores to assess each procedure were also provided by the physicians and endoscopy assistants who carried out the procedures. A statistical analysis was carried out using the Wilcoxon rank-sum test. RESULTS: Twenty-five patients with 50 interventions were examined with the VS ERCP technique, and 24 patients with 47 interventions were examined using the conventional ERCP technique. There were no significant differences between the two groups regarding the age, sex, indications, degree of ERCP difficulty, or interventions performed. The main study parameters in the VS group showed a nonsignificant trend towards a shorter interventional examination time (29 min, 5-50 min vs 31 min, 7-90 min, P = 0.28), shorter X-ray time (5.8 min, 0.6-14.1 min vs 6.1 min, 1.6-18.8 min, P = 0.48), and lower X-ray dose (1351 cGy/m(2), 159-5039 cGy/m(2) vs 1296 cGy/m(2), 202.2-6421 cGy/m(2), P = 0.34). A nonsignificant trend towards fewer adverse events occurred in the VS group as compared with the conventional ERCP group (cholangitis: 12% vs 16%, P = 0.12; pain: 4% vs 12.5%, P = 0.33; post-ERCP pancreatitis: 4% vs 12.5%, P = 0.14). In addition, there were no statistically significant differences in assessment by the physicians and endoscopy assistants using subjective questionnaires. CONCLUSION: ERCP using the short-guidewire V-system did not significantly improve ERCP performance or patient outcomes, but it may reduce and simplify the ERCP procedure in difficult settings.
Entities:
Keywords:
Bile duct stenosis; Endoscopic retrograde cholangiopancreaticography; Short guidewire endoscopic retrograde cholangiopancreaticography system; V-scope; X-ray protection
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