Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome

October 26, 2023 updated by: Mohamed Ezzat Mahmoud, Sohag University

The incidence of pancreato-biliary disorders ,including malignancy, is increasing in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known therapeutic tool for these pancreato-biliary disorders.

In general, old age is defined as being more than 65 years of age by the World Health Organization. The increase in the domestic aged population is related to the increasing demand for therapeutic ERCP in elderly patients with pancreato-biliary disorders. Common bile duct stones and cancer account for70 % of all jaundice cases in patients over the age of 65 years . This is related to increasing prevalences of cholelithiasis, choledocholithiasis, and malignancy with advancing age .

Endoscopic Retrograde Cholangiopancreatography(ERCP) represents the gold standard technique for the treatment of biliary or pancreatic tract pathology, and it could be often performed with therapeutic intent by realizing procedures such as insertion of bile duct stents and/or endoscopic sphincterotomy. However, evidence about its safety in the elderly is still controversial.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

However, therapeutic ERCP is an invasive procedure and is associated with several complications, such as bleeding, pancreatitis, cholangitis, perforation, and mortality. A higher incidence of periprocedural complications might be expected in elderly patients because of the high prevalence of concomitant medical disorders, such as cardiopulmonary and cerebrovascular diseases, and the poor general condition of this population [8].

Despite many previous reports of the safety and efficacy of ERCP in elderly patients, in real clinical practice, there is concern regarding complications of ERCP performed in patients more than 65years old. Also comparative reports of the efficacy and safety of therapeutic ERCP, especially inpatients over 65 years of age, are limited. To investigate this issue, we will evaluate the clinical outcomes such as the technical success rate, procedure-related complications rate, and anesthesia-related adverse events rate of therapeutic ERCP in a older aged group (over than 65 years of age) and control group (less than 65 years of age) at a single tertiary center.

Aim of the work This study aims to evaluate the outcome and safety of ERCP in patients with obstructive jaundice over than 65 years of age.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hassan A Hassanein, professor
  • Phone Number: 01003459741

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with obstructive jaundice older than 18 years old

Exclusion Criteria:

  • patients who refuse consent
  • patients under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
patients with obstructive jaundice equal or older than 65 years old
Procedure: Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old
Active Comparator: group B
patients with obstructive jaundice younger than 65 years old
Procedure: Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatitis
Time Frame: 12 months
serum amylase and lipase using Mann Whitney test
12 months
Cholangitis
Time Frame: 12 months
Temperature chart and serum bilirubin using Chi-square test
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: 12 months
procedure time and frequency of a second ERCP for complete success.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Mohamed E Mahmoud, Specialist, Sohag University
  • Study Director: Mohamed E Mahmoud, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-10-07MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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