NCT03104569

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

March 26, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
9 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

March 26, 2017

Last Update Submit

December 19, 2025

Conditions

Cholangitis

Keywords

ERCPContrast agentHilar cholangiocarcinomaCholangitisNonionic

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Secondary Outcomes (5)

  • The ease of injection

    During procedures

  • Number of Participants With Abnormal Laboratory Values

    4 days

  • Operation time

    intraoperative

  • X-ray exposure time

    intraoperative

  • Number of participants with Post-ERCP pancreatitis

    1 months

Study Arms (2)

Injection of 37℃ contrast agent

EXPERIMENTAL

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

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

Interventions

Injection of 37℃ contrast agentPROCEDURE

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

Injection of 37℃ contrast agent

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
  • Age: 18\~90 years old;
  • Underwent diagnostic and therapeutic ERCP;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The first hospital of Lanzhou university

Lanzhou, Gansu, 730000, China

Location

The first affiliated hospital of Xi 'an jiaotong university

Xi'an, Shaanxi, 710061, China

Location

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300100, China

Location

MeSH Terms

Conditions

CholangitisKlatskin Tumor

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Xun Li, M.D., Ph. D.

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    STUDY CHAIR

Central Study Contacts

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

CONTACT

+8613919177177mengwb@lzu.edu.cn

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

CONTACT

+8613993138612drlixun@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph. D, Director.

Study Record Dates

First Submitted

March 26, 2017

First Posted

April 7, 2017

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)