Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice

NCT07563569 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-4-3MS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare the impact of type of anesthesia on ERCP including technical success, rate of complications, peri procedural safety, patient and endoscopist satisfaction in adult patients with obstructive jaundice

Conditions

Obstructive Jaundice; ERCP; Anesthesia Complication; Anesthesia Effectiveness

Keywords

ERCP

Outcome Measures

Primary Outcomes (1)

• Impact of type of anesthesia on technical success rate

  Technical success rate defined as successful deep biliary cannulation and completion of the intended therapeutic intervention.

  at the time of the procedure

Secondary Outcomes (1)

• rate of procedure related complications

  at the time of procedure up to 72 hours post procedure

Study Arms (2)

Group A

EXPERIMENTAL

50 patient will under go procedure (ERCP) under general anesthesia (25 calcular obstructive jaundice ,25 malignant obstructive jaundice)

Procedure: ERCP

Group B

EXPERIMENTAL

50 patient will under go procedure (ERCP)under sedation (25 calcular obstructive jaundice, 25 malignant obstructive jaundice)

Procedure: ERCP

Interventions

ERCP PROCEDURE

Effect of anesthesia on Therapeutic ERCP in patients obstructive jaundice

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:

• Adult patients above 18 years old.
• Patient with obstructive jaundice as an indication for therapeutic ERCP.
• Provided written informed consent.

You may not qualify if:

• Patients below 18 years old.
• Indications for ERCP other than obstructive jaundice.
• with coagulopathy not corrected prior to procedure.
• severe active cardiopulmonary comorbidities.
• Previous altered upper GIT anatomy (e.g gastric by-pass).
• Pregnancy

Sponsors & Collaborators

• Sohag University: lead

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 Khaled Abd El-Azeem

  Tropical medicine and Gastroentrology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Khaled Abd El-Azeem

CONTACT

01066965222; Mohamed.Eed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor, Tropical Medicine and Gastroentrology

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): May 20, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04