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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034710 |
Receipt No. | R000039565 |
Official scientific title of the study | Preventive effect of post-ERCP pancreatitis by cooling the duodenal papilla with ice water |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2018/10/30 |
Basic information | ||
Official scientific title of the study | Preventive effect of post-ERCP pancreatitis by cooling the duodenal papilla with ice water | |
Title of the study (Brief title) | Ice water challenge | |
Region |
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Condition | ||
Condition | Gallbladder cancer / bile duct cancer / pancreatic cancer / bile duct stone / cholangitis / pancreatitis / pancreatic cyst / pancreatic duct stenosis / biliary dilatation etc. | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate whether to reduce the incidence of post-ERCP pancreatitis by cooling the papilla with ice water after ERCP. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Incidence of post-ERCP pancreatitis |
Key secondary outcomes | Patient background (age, sex, past history of pancreatitis, PS, ASA, drinking history, smoking history etc.).
Presence or absence of cholangitis before treatment. PEP incidence rate due to differences in ERCP procedures (bile duct obesity, pancreatic ductal purpose, EST, EPBD, biopsy, IDUS, biliary stent, pancreatic duct stent, etc.). PEP incidence rate with or without pancreatic ductal intubation/ ductography. PEP incidence rate due to bile duct intubation time. Increase frequency and degree of pancreatic enzyme and inflammatory reaction (WBC, CRP) after 2 hours of ERCP/ next day in the above items. The degree of PEP in the above items. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Before ending with ERCP, ice water is injected endoscopically into the lower duodenum to cool the duodenal papilla. Injection method uses a jet water pump, inject 500 ml of cold water (about one and a half minutes). | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | ERCP can be enforced, there is no history of nipple treatment was enforced.
The age at registration is over 20 years old. After getting enough explanation about participation in research, with sufficient understanding, written consent was obtained from the research subject himself / herself by the free will of the person him / herself. |
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Key exclusion criteria | Patient after papilla treatment
Patient in postoperative reconstructed intestinal tract Patients with pancreatitis or pancreatic enzyme elevation (more than 3 times higher than normal upper limit) before ERCP Patients who require drinking restriction due to heart failure etc. Patients who are judged inappropriate for the research director or the attending physician to conduct this study |
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Target sample size | 600 |
Research contact person | |
Name of lead principal investigator | Shunjiro Azuma |
Organization | Kitano Hospital Tazuke Kofukai Medical Research Institute |
Division name | Gastroenterology and hepatology |
Address | 2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka |
TEL | 06-6312-1221 |
s-azuma@kitano-hp.or.jp |
Public contact | |
Name of contact person | Shunjiro Azuma |
Organization | Kitano Hospital Tazuke Kofukai Medical Research Institute |
Division name | Gastroenterology and hepatology |
Address | 2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka, Japan |
TEL | 06-6312-1221 |
Homepage URL | |
s-azuma@kitano-hp.or.jp |
Sponsor | |
Institute | Kitano Hospital Tazuke Kofukai Medical Research Institute |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039565 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |