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

NCT06093048 | Unknown

• 1 other identifier: Soh-Med-23-10-07MD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Jaundice

Outcome Measures

Primary Outcomes (2)

• Pancreatitis

  serum amylase and lipase using Mann Whitney test

  12 months

• Cholangitis

  Temperature chart and serum bilirubin using Chi-square test

  12 months

Secondary Outcomes (1)

• Technical success rate

  12 months

Study Arms (2)

group A

ACTIVE COMPARATOR

patients with obstructive jaundice equal or older than 65 years old

Procedure: Endoscopic retrograde cholangiopancreatography

group B

ACTIVE COMPARATOR

patients with obstructive jaundice younger than 65 years old

Procedure: Endoscopic retrograde cholangiopancreatography

Interventions

Endoscopic retrograde cholangiopancreatography PROCEDURE

saftey and outcome in patients older than 65 years old

group A; group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with obstructive jaundice older than 18 years old

You may not qualify if:

• patients who refuse consent
• patients under 18 years old

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 28428722 BACKGROUND

• 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.

  PMID: 27565508 BACKGROUND

• 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.

  PMID: 35433228 BACKGROUND

• 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.

  PMID: 25040209 BACKGROUND

MeSH Terms

Conditions

Jaundice, Obstructive

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

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

• Mohamed E Mahmoud, Specialist

  Sohag University

  STUDY DIRECTOR

• Mohamed E Mahmoud

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

mohamed E mahmoud, spcialist

CONTACT

01280711516; mohamed.hassan4@med.sohag.edu.eg

Hassan A Hassanein, professor

CONTACT

01003459741

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of internal medicine sohag university hospital

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

EG (1)