ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events

Completed

• Conditions: Cholangitis; Post-ERCP Acute Pancreatitis
• Interventions: Diagnostic Test: ERCP

• Registration Number: NCT03771547
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief Summary

Today 11 percent of China's population is over the age of 65, and according to United Nations, it will take China just 20 years for the proportion of the elderly population to double to 25%. As life expectancy has increased, application of Endoscopic Retrograde Cholangiopancreatography (ERCP) in super-aged (≥80 years of age) is no longer limited with increasing prevalence of choledocholithiasis, and malignancy in advancing age. This increasing may come with more difficulty in cannulation or more complications in senior patients. Regarding difficult cannulation, little is known about grading difficulty in the elderly and its relation with adverse events. Therefore, it is time to evaluate the risk factors of adverse events in super-aged patients with difficult bile duct cannulation.

Detailed Description

AIM: To evaluate the incidence, causes, and management of difficult biliary cannulation during ERCP in elderly patients and its role as a risk factor for adverse events.

METHODS: A total of 614 patients, with a mean age of 65.3±16.7 years, underwent ERCP during the study period, were prospectively managed and divided into two groups based on their age. There were 146 patients aged 80 years or older in group A with the mean age of 84±3.4 years. The primary outcome measurements were the difficulty grade of papilla cannulation, clinical outcomes, and ERCP-related complications in the two groups. The adverse events were analyzed by logistic regression about patient age, co-morbidities, indications, and difficult cannulation grading.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2018-01-30
• Status Verified: 2018-02
• Study Completion: 2018-03-01
• Study First Submitted: 2018-10-07
• Study First Submitted QC: 2018-12-08
• Last Update Submitted: 2018-12-08
• Study First Posted: 2018-12-11
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

• Patients who underwent ERCP between July 2016 and January 2018.

Exclusion Criteria

• We excluded the patients who underwent ERCP for the objectives of follow up, stent removing or taking a biopsy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Less 80	ERCP	The second group included those ERCP patients younger than 80.
More 80	ERCP	The first group included ERCP patients aged 80 and above.

Primary Outcome Measures

Name	Time	Method
Adverse events in difficult cannulation patients	30 days	Multi-variate regression will be used to check the risk factors of adverse events

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China