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

Obstructive Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093048
• Other study ID #: Soh-Med-23-10-07MD
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Sohag University
• Contact: mohamed E mahmoud, spcialist
• Phone: 01280711516
• Email: mohamed.hassan4[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with obstructive jaundice older than 18 years old

Exclusion Criteria:

• patients who refuse consent

• patients under 18 years old

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice

Intervention

Procedure:
• Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatitis	serum amylase and lipase using Mann Whitney test	12 months
Primary	Cholangitis	Temperature chart and serum bilirubin using Chi-square test	12 months
Secondary	Technical success rate	procedure time and frequency of a second ERCP for complete success.	12 months