Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial.
OBJECTIVE
The allocation of sufficient time for trainees to attempt cannulation is necessary for learning and to ensure success with endoscopic retrograde cholangiopancreatography (ERCP) training. However, it is important to balance the benefit to trainee practice against the potential risks to patients. The appropriate time for attempted cannulation by trainees remains unclear.


METHODS
Three different time limits (5, 10, 15 minutes) were set for cannulation attempts made by four trainees in patients with native papilla undergoing ERCP. Patients were randomly assigned to the 5-, 10-, or 15-minute groups in a 1:1:1 ratio. Rectal indomethacin was used in high-risk patients. The primary outcome was successful cannulation within the allocated time. Secondary outcomes included performance scores, overall success rate, and post-ERCP pancreatitis (PEP).


RESULTS
A total of 256 patients were randomly assigned to the 5-minute (n = 84), 10-minute (n = 86), or 15-minute (n = 86) groups. Patients' baseline characteristics were comparable. Success rates for selective bile duct cannulation by trainees were 43.8 %, 75.0 %, and 71.8 % in the 5-, 10-, and 15-minute groups, respectively (P < 0.001). Trainees' self-reported performance scores and video assessment by an independent reviewer were comparable between the 10- and 15-minute groups, which were higher than the 5-minute group (both P  < 0.001). Trainers took over the cannulation procedure when trainees did not succeed within the allocated time. There was no significant difference in the overall success rates in cannulation between the three groups. No differences were noted in the use of rectal indomethacin and overall complication rates. Four patients in each group developed PEP (P = 0.996).


CONCLUSIONS
A time of 10 minutes was considered to be appropriate for trainees to attempt cannulation, with acceptable cannulation success rates and complications.


BACKGROUND
ClinicalTrials.gov number (NCT01851226).
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Yanglin
Y
Pan
Department of Radiotherapy, Xijing Hospital, Fourth Military Medical University, Xian, China.
Lina
L
Zhao
Gastroenterology, Sacramento VA Medical Center, VANCHCS, Mather, and UC Davis Medical Center, Sacramento, California, USA.
Joseph
J
Leung
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Rongchun
R
Zhang
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Hui
H
Luo
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Xiangping
X
Wang
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Zhiguo
Z
Liu
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Bingnian
B
Wan
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Qin
Q
Tao
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Shaowei
S
Yao
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Na
N
Hui
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Daiming
D
Fan
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Kaichun
K
Wu
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Xuegang
X
Guo
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001649:Bile Duct Diseases / Q000175:diagnosis / Q000628:therapy*; D002404:Catheterization / Q000379:methods*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods*; D004502:Education, Medical, Continuing / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005762:Gastroenterology / Q000193:education*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010183:Pancreatic Ducts; D015203:Reproducibility of Results; D013997:Time Factors; D055815:Young Adult