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

NCT ID: NCT03771547

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

614 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Post-ERCP Acute Pancreatitis Cholangitis

Keywords

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ERCP Elderly Difficult cannulation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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More 80

The first group included ERCP patients aged 80 and above.

ERCP

Intervention Type DIAGNOSTIC_TEST

Less 80

The second group included those ERCP patients younger than 80.

ERCP

Intervention Type DIAGNOSTIC_TEST

Interventions

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ERCP

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

94 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin Miao, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Tabak F, Ji GZ, Miao L. Impact of periampullary diverticulum on biliary cannulation and ERCP outcomes: a single-center experience. Surg Endosc. 2021 Nov;35(11):5953-5961. doi: 10.1007/s00464-020-08080-8. Epub 2020 Oct 7.

Reference Type DERIVED
PMID: 33029732 (View on PubMed)

Other Identifiers

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DC-0918

Identifier Type: -

Identifier Source: org_study_id