NCT03771547

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 614 (actual)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 16 Years – 94 Years
• Healthy volunteers: —

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.

Conditions

• Post-ERCP Acute Pancreatitis
• Cholangitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ERCP

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-01-30
• Completion: 2018-03-01
• First posted: 2018-12-11
• Last updated: 2018-12-11

Locations

1 site across 1 country: China