ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events
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|ClinicalTrials.gov Identifier: NCT03771547|
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment|
|Post-ERCP Acute Pancreatitis Cholangitis||Diagnostic Test: ERCP|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||614 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events|
|Actual Study Start Date :||July 1, 2016|
|Actual Primary Completion Date :||January 30, 2018|
|Actual Study Completion Date :||March 1, 2018|
The first group included ERCP patients aged 80 and above.
Diagnostic Test: ERCP
The second group included those ERCP patients younger than 80.
Diagnostic Test: ERCP
- Adverse events in difficult cannulation patients [ Time Frame: 30 days ]Multi-variate regression will be used to check the risk factors of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771547
|Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University|
|Nanjing, Jiangsu, China, 210011|
|Principal Investigator:||Lin Miao, PhD||Nanjing Medical University|