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New 'Smart' cut during ERCP aims to slash complication rates

NCT ID NCT04406961

Disease control Sponsor: Military Medical Clinical Center of the Southern Region, Ukraine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to open the bile duct during an ERCP procedure. Instead of the standard pull-type cut, doctors used a special hooked knife (ASD) designed to cut only the circular muscle layer, potentially causing less damage. Over 1,500 patients were randomly assigned to get either the new or standard technique. The main goal was to see if the new method led to fewer serious problems like bleeding, pancreatitis, or a hole in the bowel.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Antegrade Sphincterotomy Dovbenko (ASD) procedure using a special sphincterotome
What this could lead to
If successful, ASD could become a safer standard technique for opening the bile duct during ERCP, reducing the risk of serious complications like bleeding and pancreatitis.
What could go wrong
This is a completed trial, but the technique is patented and not widely adopted. Results may not apply to all patients or settings, and the procedure requires specialized training and equipment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,521 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 102 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Clinical diagnosis of Gallstone Disease. Must have anatomy of the esophagus of the stomach and duodenum for the introduction of a duodenoscope to the major duodenal papilla. Exclusion Criteria: The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer choledocholithiasis cholelithiasis cholestasis gallstones

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign biliary strictures with current or prior biliary obstruction Biliary obstruction Choledocholithiasis External biliary fistula Gallstone disease Malignant biliary obstruction Papillary stenosis

Contacts and locations

Locations

  • Oleg Dovbenko

    Odesa, Odesa Oblast, 65044, Ukraine

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