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NCT Number: NCT03771547

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

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.

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Key information

Conditions

Post-ERCP Acute Pancreatitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Digestive System Diseases

Age range

16 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERCP

Diagnostic Test

Primary outcomes

  1. Adverse events in difficult cannulation patients

    Time frame: 30 days

    Multi-variate regression will be used to check the risk factors of adverse events

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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