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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06093048
Collaborator
(none)
100
1
2
11
9.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic retrograde cholangiopancreatography
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pancreatitis [12 months]

    diagnosed by post ERCP elevation of serum amylase and lipase

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with obstructive jaundice older than 18 years old
Exclusion Criteria:
    1. patients who refuse consent 2. patients under 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Ezzat Mahmoud, specialist of internal medicine sohag university hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT06093048
Other Study ID Numbers:
  • Soh-Med-23-10-07MD
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023