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

Study Overview
=================
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.

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

Conditions
-----------------
Post-ERCP Acute Pancreatitis, Cholangitis

Intervention / Treatment
-----------------
* Diagnostic Test: ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 94 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| More 80<br>The first group included ERCP patients aged 80 and above. | Diagnostic Test: ERCP<br> <br> |
| Less 80<br>The second group included those ERCP patients younger than 80. | Diagnostic Test: ERCP<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events in difficult cannulation patients | Multi-variate regression will be used to check the risk factors of adverse events | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, Elderly, Difficult cannulation