Clinical trial · Interventional
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study
NCT03104569CI-TRIAL-00099670not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of 37℃ contrast agent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Injection of 37℃ contrast agent
- description
- Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent
- interventionNames
- Procedure: Injection of 37℃ contrast agent
- type
- NO_INTERVENTION
- label
- Injection of normal contrast agent
- description
- Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent
Primary outcomes (1)
- measure
- Number of participants with Acute cholangitis
- timeFrame
- 2 weeks
- description
- Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.