Obstructive JaundiceERCPNCT07563569
Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice
A study testing ERCP in people with Obstructive Jaundice and ERCP, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Jaundice, ERCP, Anesthesia Complication
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients above 18 years old.
- Patient with obstructive jaundice as an indication for therapeutic ERCP.
- Provided written informed consent.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice: A Prospective Comparative Study.
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
- Being tested
- ERCP
- Keywords
- ERCP
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Effect of anesthesia on Therapeutic ERCP in patients obstructive jaundice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 50 patient will under go procedure (ERCP) under general anesthesia (25 calcular obstructive jaundice ,25 malignant obstructive jaundice) Receives: Procedure: ERCP |
| Group B | Experimental | 50 patient will under go procedure (ERCP)under sedation (25 calcular obstructive jaundice, 25 malignant obstructive jaundice) Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the time of the procedure
Secondary outcomes (1)
rate of procedure related complications
Procedure related complication exclusively (post ERCP pancreatitis (based on revised Atlanta criteria), bleeding, perforation, cholangitis and aspiration pneumonia)
Measured: at the time of procedure up to 72 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start20 May 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khaled Abdelazim, Sohag University
- Investigators
- Mohamed Khaled Abd El-Azeem, Principal investigator, Tropical medicine and Gastroentrology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563569
- Sponsor's protocol ID
- Soh-Med-26-4-3MS
- Acronym
- ERCP
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice: A Prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT07563569
- Acronym / sponsor ID
- ERCP / Soh-Med-26-4-3MS
- Keywords
- ERCP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: ERCP50 patient will under go procedure (ERCP) under general anesthesia (25 calcular obstructive jaundice ,25 malignant obstructive jaundice) |
| Group B | Experimental | Procedure: ERCP50 patient will under go procedure (ERCP)under sedation (25 calcular obstructive jaundice, 25 malignant obstructive jaundice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients above 18 years old.
- Patient with obstructive jaundice as an indication for therapeutic ERCP.
- Provided written informed consent.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPEffect of anesthesia on Therapeutic ERCP in patients obstructive jaundice | Procedure or surgery | Group A, Group B |
Primary outcome
Impact of type of anesthesia on technical success rate
Time frame: at the time of the procedure
Technical success rate defined as successful deep biliary cannulation and completion of the intended therapeutic intervention.
1 secondary outcome
rate of procedure related complications
Time frame: at the time of procedure up to 72 hours post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Calcular Obstructive Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Khaled Abd El-Azeem principal investigator
Tropical medicine and Gastroentrology department
Questions about this trial
What is this clinical trial studying?
A study testing ERCP in people with Obstructive Jaundice and ERCP, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khaled Abd El-Azeem (01066965222, Mohamed.Eed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of type of anesthesia on technical success rate (time frame: at the time of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.