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Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma

NCT ID: NCT03104569

Last Updated: 2025-12-26

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2028-12-01

Brief Summary

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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

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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

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Cholangitis

Keywords

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ERCP Contrast agent Hilar cholangiocarcinoma Cholangitis Nonionic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Injection of 37℃ contrast agent

Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent

Group Type EXPERIMENTAL

Injection of 37℃ contrast agent

Intervention Type PROCEDURE

Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent

Injection of normal contrast agent

Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Injection of 37℃ contrast agent

Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Xun Li

M.D., Ph. D, Director.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xun Li, M.D., Ph. D.

Role: STUDY_CHAIR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

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The first hospital of Lanzhou university

Lanzhou, Gansu, China

Site Status

The first affiliated hospital of Xi 'an jiaotong university

Xi'an, Shaanxi, China

Site Status

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Central Contacts

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Wenbo Meng, M.D., Ph. D.

Role: CONTACT

Phone: +8613919177177

Email: [email protected]

Xun Li, M.D., Ph. D.

Role: CONTACT

Phone: +8613993138612

Email: [email protected]

Facility Contacts

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Wence Zhou, M. D.

Role: primary

Wenbo Meng, M. D.

Role: backup

Hao Sun, M. D.

Role: primary

Zhenyu Wang, M. D.

Role: primary

Other Identifiers

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37℃ Contrast Agent in ERCP

Identifier Type: -

Identifier Source: org_study_id