CholangitisNCT03104569
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma
A study testing Injection of 37℃ contrast agent in people with Cholangitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 3 sites in China.
Trial summary
The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangitis
- What is being tested?
- Injection of 37℃ contrast agent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2026to 1 Dec 2028
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
- Age: 18~90 years old;
- Underwent diagnostic and therapeutic ERCP;
Who cannot join
- 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;
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The first hospital of Lanzhou university
Lanzhou, Gansu, 730000
Wence Zhou, M. D., +8609318356919, zhouwc129@163.com
Wenbo Meng, M. D., +8609318356213, mengwb@lzu.edu.cn
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300100
Zhenyu Wang, M. D., +86 15302021661, Wangzytj@163.com
The first affiliated hospital of Xi 'an jiaotong university
Xi'an, Shaanxi, 710061
Hao Sun, M. D., +86 13891813691, sunhaoxjfy@126.com
About this study
Official title: Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study
The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.
Read the detailed description
At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.
- Conditions
- Cholangitis
- Being tested
- Injection of 37℃ contrast agent
- Keywords
- ERCP, Contrast agent, Hilar cholangiocarcinoma, Cholangitis, Nonionic
- Medical subject headings
- Cholangitis, Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 37℃ contrast agentProcedure or surgery
Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Injection of 37℃ contrast agent | Experimental | Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent Receives: Procedure: Injection of 37℃ contrast agent |
| Injection of normal contrast agent | No intervention | Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Acute cholangitis
Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks
Measured: 2 weeks
Secondary outcomes (5)
The ease of injection
The ease of contrast agent injection has been considered by ERCP assistant, a questionnaire is required to assign by the assistant
Measured: During procedures
Number of Participants With Abnormal Laboratory Values
9 parameter will be collected in day 2 and day 4 after procedures. Abnormal in Total bilirubin (TBIL), White Blood Count (WBC), N%,Platelet( PLT), Procalcitonin(PCT) or C-reactive protein(CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and Gamma - glutamyl transpeptidase (GGT) required to be documented
Measured: 4 days
Operation time
Total time of procedure
Measured: intraoperative
X-ray exposure time
The total time of X-ray exposure
Measured: intraoperative
Number of participants with Post-ERCP pancreatitis
Post-ERCP pancreatitis is defined if patients experienced abdominal pain for more than 24h after ERCP, accompanying with amylase or lipase more than 3 times equal to the upper limit of normal value.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangitisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Xun Li, M.D., Ph. D., Study chair, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104569
- Sponsor's protocol ID
- 37℃ Contrast Agent in ERCP
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2017
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03104569
- Acronym / sponsor ID
- 37℃ Contrast Agent in ERCP
- Conditions
- Cholangitis
- Keywords
- ERCP, Contrast agent, Hilar cholangiocarcinoma, Cholangitis, Nonionic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 7 Apr 2017 (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.
The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.
Detailed description
At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection of 37℃ contrast agent | Experimental | Procedure: Injection of 37℃ contrast agentNonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent |
| Injection of normal contrast agent | No intervention | –Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
- Age: 18~90 years old;
- Underwent diagnostic and therapeutic ERCP;
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| Injection of 37℃ contrast agentNonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent | Procedure or surgery | Injection of 37℃ contrast agent |
Primary outcome
Number of participants with Acute cholangitis
Time frame: 2 weeks
Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks
5 secondary outcomes
The ease of injection
Time frame: During procedures
Number of Participants With Abnormal Laboratory Values
Time frame: 4 days
Operation time
Time frame: intraoperative
X-ray exposure time
Time frame: intraoperative
Number of participants with Post-ERCP pancreatitis
Time frame: 1 months
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 26 Dec 2025.
- 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.
Xun Li, M.D., Ph. D. study chair
Hepatopancreatobiliary Surgery Institute of Gansu Province
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of 37℃ contrast agent in people with Cholangitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 3 sites in China.
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 11 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
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 Wenbo Meng, M.D., Ph. D. (+8613919177177, mengwb@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Acute cholangitis (time frame: 2 weeks). 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 26 Dec 2025.