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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03771547
Enrollment
614
Registered
2018-12-11
Start date
2016-07-01
Completion date
2018-03-01
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis, Post-ERCP Acute Pancreatitis

Keywords

ERCP, Elderly, Difficult cannulation

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.

Interventions

DIAGNOSTIC_TESTERCP

Sponsors

The Second Hospital of Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 94 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Adverse events in difficult cannulation patients30 daysMulti-variate regression will be used to check the risk factors of adverse events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026