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

NCT03771547 | Completed DMC

• 1 other identifier: DC-0918
• Study Type: observational
• Target: 614
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Acute Pancreatitis; Cholangitis

Keywords

ERCP; Elderly; Difficult cannulation

Outcome Measures

Primary Outcomes (1)

• Adverse events in difficult cannulation patients

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

  30 days

Study Arms (2)

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

Interventions

ERCP DIAGNOSTIC_TEST

Less 80; More 80

Eligibility Criteria

• Age: 16 Years - 94 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

No specific restrictions on selecting the patients.

You may qualify if:

• Patients who underwent ERCP between July 2016 and January 2018.

You may not qualify if:

• We excluded the patients who underwent ERCP for the objectives of follow up, stent removing or taking a biopsy.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

Location

Related Publications (1)

• 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.

  PMID: 33029732 DERIVED

MeSH Terms

Conditions

Cholangitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Lin Miao, PhD

  Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: December 11, 2018
• Study Start: July 1, 2016
• Primary Completion: January 30, 2018
• Study Completion: March 1, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-02

Locations

CN (1)