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

Primary Purpose

Obstructive Jaundice

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Endoscopic retrograde cholangiopancreatography

About this trial

This is an interventional screening trial for Obstructive Jaundice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with obstructive jaundice older than 18 years old Exclusion Criteria: 1. patients who refuse consent 2. patients under 18 years old

Sites / Locations

Sohag university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group A

group B

Arm Description

patients with obstructive jaundice equal or older than 65 years old

patients with obstructive jaundice younger than 65 years old

Outcomes

Primary Outcome Measures

Pancreatitis

diagnosed by post ERCP elevation of serum amylase and lipase

Secondary Outcome Measures

Full Information

NCT ID

NCT06093048

First Posted

October 19, 2023

Last Updated

October 19, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT06093048

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Jaundice

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

patients with obstructive jaundice equal or older than 65 years old

Arm Title

group B

Arm Type

Active Comparator

Arm Description

patients with obstructive jaundice younger than 65 years old

Intervention Type

Procedure

Intervention Name(s)

Endoscopic retrograde cholangiopancreatography

Intervention Description

saftey and outcome in patients older than 65 years old

Primary Outcome Measure Information:

Title

Pancreatitis

Description

diagnosed by post ERCP elevation of serum amylase and lipase

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with obstructive jaundice older than 18 years old Exclusion Criteria: 1. patients who refuse consent 2. patients under 18 years old

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mohamed E mahmoud, spcialist

Phone

01280711516

mohamed.hassan4@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Hassan A Hassanein, professor

Phone

01003459741

Facility Information:

Facility Name

Sohag university Hospital

City

Sohag

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magdy M Amin, professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

28428722

Citation

Zhang ZM, Liu Z, Liu LM, Zhang C, Yu HW, Wan BJ, Deng H, Zhu MW, Liu ZX, Wei WP, Song MM, Zhao Y. Therapeutic experience of 289 elderly patients with biliary diseases. World J Gastroenterol. 2017 Apr 7;23(13):2424-2434. doi: 10.3748/wjg.v23.i13.2424.

Results Reference

background

PubMed Identifier

27565508

Citation

Ukkonen M, Siiki A, Antila A, Tyrvainen T, Sand J, Laukkarinen J. Safety and Efficacy of Acute Endoscopic Retrograde Cholangiopancreatography in the Elderly. Dig Dis Sci. 2016 Nov;61(11):3302-3308. doi: 10.1007/s10620-016-4283-2. Epub 2016 Aug 26.

Results Reference

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PubMed Identifier

35433228

Citation

Perisetti A, Goyal H, Sharma N. Clinical safety and outcomes of glucagon use during endoscopic retrograde cholangiopancreatography (ERCP). Endosc Int Open. 2022 Apr 14;10(4):E558-E561. doi: 10.1055/a-1747-3242. eCollection 2022 Apr.

Results Reference

background

PubMed Identifier

25040209

Citation

Holt BA. Increased severity of post-endoscopic retrograde cholangiopancreatography complications in the elderly: an issue to be addressed. Dig Endosc. 2014 Jul;26(4):534-5. doi: 10.1111/den.12298. No abstract available.

Results Reference

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

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