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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection of 37℃ contrast agent | Experimental | Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent |
|
| Injection of normal contrast agent | No Intervention | Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of 37℃ contrast agent | Procedure | Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During procedures |
| Number of Participants With Abnormal Laboratory Values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbo Meng, M.D., Ph. D. | Contact | +8613919177177 | mengwb@lzu.edu.cn | |
| Xun Li, M.D., Ph. D. | Contact | +8613993138612 | drlixun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xun Li, M.D., Ph. D. | Hepatopancreatobiliary Surgery Institute of Gansu Province | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Lanzhou university | Lanzhou | Gansu | 730000 | China |
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D018281 | Cholangiocarcinoma |
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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
| 4 days |
| Operation time | Total time of procedure | intraoperative |
| X-ray exposure time | The total time of X-ray exposure | intraoperative |
| 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. | 1 months |
| The first affiliated hospital of Xi 'an jiaotong university | Xi'an | Shaanxi | 710061 | China |
|
| Tianjin Nankai Hospital | Tianjin | Tianjin Municipality | 300100 | China |
|
| D000230 |
| Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |