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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
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Nanjing Medical University

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.

Condition or disease Intervention/treatment
Post-ERCP Acute Pancreatitis Cholangitis Diagnostic Test: ERCP

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 614 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
More 80
The first group included ERCP patients aged 80 and above.
Diagnostic Test: ERCP
Less 80
The second group included those ERCP patients younger than 80.
Diagnostic Test: ERCP



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 94 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
No specific restrictions on selecting the patients.
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.

Information from the National Library of Medicine

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


Locations
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China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Principal Investigator: Lin Miao, PhD Nanjing Medical University

Additional Information:

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Responsible Party: The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03771547     History of Changes
Other Study ID Numbers: DC-0918
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Second Hospital of Nanjing Medical University:
ERCP
Elderly
Difficult cannulation

Additional relevant MeSH terms:
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Pancreatitis
Cholangitis
Pancreatic Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases