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

Primary Purpose

Cholangitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Injection of 37℃ contrast agent

About this trial

This is an interventional treatment trial for Cholangitis focused on measuring ERCP, Contrast agent, Hilar cholangiocarcinoma, Cholangitis, Nonionic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The first hospital of Lanzhou university
The first affiliated hospital of Xi 'an jiaotong university
Tianjin Nankai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Injection of 37℃ contrast agent

Injection of normal contrast agent

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Operation time

Total time of procedure

X-ray exposure time

The total time of X-ray exposure

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.

Full Information

NCT ID

NCT03104569

First Posted

March 26, 2017

Last Updated

July 25, 2023

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

1. Study Identification

Unique Protocol Identification Number

NCT03104569

Brief Title

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

Official Title

Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2025 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangitis

Keywords

ERCP, Contrast agent, Hilar cholangiocarcinoma, Cholangitis, Nonionic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Injection of 37℃ contrast agent

Arm Type

Experimental

Arm Description

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

Arm Title

Injection of normal contrast agent

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Injection of 37℃ contrast agent

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with Acute cholangitis

Description

Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

The ease of injection

Description

The ease of contrast agent injection has been considered by ERCP assistant, a questionnaire is required to assign by the assistant

Time Frame

During procedures

Title

Number of Participants With Abnormal Laboratory Values

Description

Time Frame

4 days

Title

Operation time

Description

Total time of procedure

Time Frame

intraoperative

Title

X-ray exposure time

Description

The total time of X-ray exposure

Time Frame

intraoperative

Title

Number of participants with Post-ERCP pancreatitis

Description

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.

Time Frame

1 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+8613919177177

mengwb@lzu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+8613993138612

drlixun@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Hepatopancreatobiliary Surgery Institute of Gansu Province

Official's Role

Study Chair

Facility Information:

Facility Name

The first hospital of Lanzhou university

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wence Zhou, M. D.

Phone

+8609318356919

zhouwc129@163.com

First Name & Middle Initial & Last Name & Degree

Wenbo Meng, M. D.

Phone

+8609318356213

mengwb@lzu.edu.cn

Facility Name

The first affiliated hospital of Xi 'an jiaotong university

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao Sun, M. D.

Phone

+86 13891813691

sunhaoxjfy@126.com

Facility Name

Tianjin Nankai Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300100

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhenyu Wang, M. D.

Phone

+86 15302021661

Wangzytj@163.com

12. IPD Sharing Statement

Plan to Share IPD

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

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