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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771547
• Other study ID #: DC-0918
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: February 2018
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: March 1, 2018
• Est. primary completion date: January 30, 2018
• Gender: All
• Age group: 16 Years to 94 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Diagnostic Test:
• ERCP

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events in difficult cannulation patients	Multi-variate regression will be used to check the risk factors of adverse events	30 days