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Warm dye may prevent infection after bile duct procedure

NCT ID NCT03104569

Symptom relief Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether warming the contrast dye to body temperature (37°C) before injecting it during an ERCP procedure can lower the chance of infection (cholangitis) in people with hilar cholangiocarcinoma (a type of bile duct cancer). About 100 adults aged 18-90 who need an ERCP will take part. The main goal is to see if the warm dye reduces fever, belly pain, or chills in the two weeks after the procedure.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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 90 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: * Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma; * Age: 18\~90 years old; * Underwent diagnostic and therapeutic ERCP; Exclusion Criteria: * Coagulation dysfunction(INR\>1.3) or/and low peripheral blood platelet count （PLT \<50x10\^9/L）; * Preoperative acute cholangitis; * Preoperative acute pancreatitis; * Preoperative hemobilia or hemorrhage of digestive tract; * Preoperative liver failure; * Combined with Mirizzi syndrome and intrahepatic bile duct stones; * Preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma; * Biliary-duodenal fistula confirmed during ERCP; * A history of reconstructive surgery for upper digestive tract except Billroth Ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum; * Previous ERCP; * Pregnant women

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Conditions

The condition(s) this trial relates to.

cholangitis hilar cholangiocarcinoma

As listed by the trial registrant

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

Cholangitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The first affiliated hospital of Xi 'an jiaotong university

    Xi'an, Shaanxi, 710061, China

  • The first hospital of Lanzhou university

    Lanzhou, Gansu, 730000, China

  • Tianjin Nankai Hospital

    Tianjin, Tianjin Municipality, 300100, China

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