Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-07-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Urgent ERCP

Urgent ERCP (\<24 Hours).

Group Type EXPERIMENTAL

ERCP

Intervention Type PROCEDURE

Repeat ERCP

Early ERCP

Early ERCP(24 to 48 Hours).

Group Type EXPERIMENTAL

ERCP

Intervention Type PROCEDURE

Repeat ERCP

Interventions

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ERCP

Repeat ERCP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who met criteria for a definite diagnosis acute cholangitis.

Exclusion Criteria

* 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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No