COMPLICATIONS OF ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY(ERCP): A PROSPECTIVE COHORT STUDY

Aims To assess Adverse Event(AE) of ERCP in India.

Methods Prospective observational cohort study. Consecutive patients with native papilla referred for ERCP in two tertiary-care centers, one academic-public and other private, between August, 2018 to July, 2019, in Kolkata, India were enrolled, if they satisfied the inclusion and exclusion criteria, after informed consent. ERCP was done in prone position under conscious sedation with Propofol according to standard indications. The pre-ERCP and peri-procedural details were recorded in a structured Proforma. The definition of AEs and Incidents were according to ASGE Quality Task Force Recommendations 2010. Post-ERCP all patients were followed for 30-days, either physically or on telephone or by contacting the treating physician. Institutional Ethical Clearance was obtained. Standard statistical analysis was performed. A two-tailed p-value<0.05 was considered significant.

Results 795/929(86%) had follow-up for AE assessment. At baseline: age(mean±SD) 47.8±15.7; Males 252(32%); Outpatients 613(77%); academic-hospital 578(73%); ASA grade I/II 738(93%); ASGE grade of procedural complexity I/II 610(77%); ERCP for Choledocholithiasis 610(77%); target duct for intervention CBD 779(98%); advanced endoscopist(>2000 procedures performed in past) 612(77%). 93(11.7%) patients had 97 post-ERCP Incidents; single 89 and double 4 ([Table 1]). 149(18.7%) patients developed 159 AEs; single 141, double 6 and triple in 2; Mild:Moderate:Severe::74:47:14. They were: Cholangitis 42(5.3%); Pain, not pancreatitis/perforation 31(3.9%); Post-ERCP Pancreatitis[PEP] 25(3.2%); Perforation 12(1.5%); Bleed 12(1.5%); Cholecystitis 15(1.9%); Others 20(2.5%). 7 AEs developed between 14-30d time-frame. 21(2.6%) with AE died (Cholangitis=11; PEP=2; perforation=2; Sudden Cardiac Death[SCD]=2; suspected air-embolism=1; Bleed=1; Infected WON=1; Unknown=1).

Table 1

	Intra-procedure	Post-procedure, i.e.,≤14 days	Late, i.e., > 14 days	Adjunct Therapy received
Pain (N=39)	1	36	2	26
Bleed (N=35)	35	0	0	5
Hypoxia (N=10)	10	0	0	0
Others (N=13)	1	12	0	5

Conclusions Post-ERCP AE profile may vary according to geography. CTRI/2019/01/017161.

Publication History

Article published online:
14 April 2022