Clinical trial NCT03104569: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cholangitis
Keywords: ERCP
Contrast agent
Hilar cholangiocarcinoma
Cholangitis
Nonionic
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with Acute cholangitis
timeFrame: 2 weeks
Secondary outcomes:
measure: The ease of injection
timeFrame: During procedures
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 4 days
measure: Operation time
timeFrame: intraoperative
measure: X-ray exposure time
timeFrame: intraoperative
measure: Number of participants with Post-ERCP pancreatitis
timeFrame: 1 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The first hospital of Lanzhou university
state: Gansu
city: Xi'an
country: China
facility: The first affiliated hospital of Xi 'an jiaotong university
state: Shaanxi
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D., Ph. D.
role: STUDY_CHAIR
References: