Clinical trial NCT03771547: ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events
Official title: ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-ERCP Acute Pancreatitis
Cholangitis
Keywords: ERCP
Elderly
Difficult cannulation
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 614
Sex: ALL
Minimum age (years): 16
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: No specific restrictions on selecting the patients.

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.

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.

Primary outcomes:
measure: Adverse events in difficult cannulation patients
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Lin Miao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.