Acute CholangitisNCT05920954
Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis
A study testing ERCP in people with Acute Cholangitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Cholangitis
- 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
- 304 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jun 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met criteria for a definite diagnosis acute cholangitis.
Who cannot join
- Patients with severe acute cholangitis at admission.
- Age < 18 years.
- Pregnancy.
- Associated Acute Severe Pancreatitis.
- Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage.
- Not giving consent.
Trial locations and contacts
1 site in 1 country.
About this study
Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure.
Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.
- Conditions
- Acute Cholangitis
- Being tested
- ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Repeat ERCP
| Study group | Role | What they receive |
|---|---|---|
| Urgent ERCP | Experimental | Urgent ERCP (<24 Hours). Receives: Procedure: ERCP |
| Early ERCP | Experimental | Early ERCP(24 to 48 Hours). Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
To perform a single-centre, randomized trial comparing the efficacy (the ability to produce a desired or intended result) of urgent versus early ERCP (Endoscopic retrograde cholangiopancreatography) for reducing the risk of 30 days of mortality.
Measured: Two Years
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
PRIMARY OUTCOME: 30 day mortality
Measured: Two Years
Secondary outcomes (1)
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
- Organ failure.
- In Hospital mortality.
- Hospital stay.
- Need for reintervention.
- Need for readmission.
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start30 Jun 2023
- Primary completion10 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute CholangitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920954
- Sponsor's protocol ID
- Urgent ERCP vs Early ERCP
- Status last verified
- Jul 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jagtap N, Rughwani H, Talukdar R, Chavan D, Memon SF, Asif S, Kulkarni AV, Kalapala R, Ramchandani M, Lakhtakia S, Darisetty S, Venkat Rao G, Tandan M, Bruno MJ, Reddy ND. Urgent versus early ERCP in mild-to-moderate acute cholangitis: a randomised controlled trial. Gut. 2026 May 20:gutjnl-2025-337279. doi: 10.1136/gutjnl-2025-337279. Online ahead of print.
PubMed 42161575
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis
- ClinicalTrials.gov ID
- NCT05920954
- Acronym / sponsor ID
- Urgent ERCP vs Early ERCP
- Conditions
- Acute Cholangitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 27 Jun 2023 (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.
Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure.
Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgent ERCP | Experimental | Procedure: ERCPUrgent ERCP (<24 Hours). |
| Early ERCP | Experimental | Procedure: ERCPEarly ERCP(24 to 48 Hours). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who met criteria for a definite diagnosis acute cholangitis.
Key exclusion criteria (6 listed)
- Patients with severe acute cholangitis at admission.
- Age < 18 years.
- Pregnancy.
- Associated Acute Severe Pancreatitis.
- Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage.
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 |
|---|---|---|
| ERCPRepeat ERCP | Procedure or surgery | Early ERCP, Urgent ERCP |
Primary outcome
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
Time frame: Two Years
To perform a single-centre, randomized trial comparing the efficacy (the ability to produce a desired or intended result) of urgent versus early ERCP (Endoscopic retrograde cholangiopancreatography) for reducing the risk of 30 days of mortality.
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
Time frame: Two Years
PRIMARY OUTCOME: 30 day mortality
1 secondary outcome
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
Time frame: Two Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 42161575Jagtap N, Rughwani H, Talukdar R, Chavan D, Memon SF, Asif S, Kulkarni AV, Kalapala R, Ramchandani M, Lakhtakia S, Darisetty S, Venkat Rao G, Tandan M, Bruno MJ, Reddy ND. Urgent versus early ERCP in mild-to-moderate acute cholangitis: a randomised controlled trial. Gut. 2026 May 20:gutjnl-2025-337279. doi: 10.1136/gutjnl-2025-337279. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP in people with Acute Cholangitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 1 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: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization (time frame: Two Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920954, which also lists 1 linked publication.
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 2 Oct 2025.