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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000018032 |
Receipt No. | R000020629 |
Scientific Title | Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome. |
Date of disclosure of the study information | 2015/08/01 |
Last modified on | 2018/12/24 |
Basic information | ||
Public title | Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome. | |
Acronym | Cannulation Study | |
Scientific Title | Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome. | |
Scientific Title:Acronym | Cannulation Study | |
Region |
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Condition | ||||
Condition | Of all diseases needed to perform ERC.
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Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Initial use of rotatable sphincterotome facilitate common bile duct cannulation and reduce risk of post ERCP pancreatitis |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | The primary endpoint is successful selective bile duct cannulation within 10 miniutes and 10 times after randomization. |
Key secondary outcomes | The secondary endpoints are successful final selective bile duct cannulation rates, procedure success rate, selective bile duct cannulation time, number of attempts at bile duct cannulation, number of accidental pancreatic duct insertions, procedure time, radiation exposure time, use of precutting for selective bile duct cannulation, and complications including PEP rates in the randomized patients and also in the initially enrolled cohort. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Rotatable shincterotome | |
Interventions/Control_2 | Conventional sphincterotome | |
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 | 1. In patients with native papilla. | |||
Key exclusion criteria | 1. In patients with ECOG Perfoemance Status Grade 4.
2. In patients with impaired consciousness. 3. In patients with suspected pancreatobiliary maljunction. 4. In patients with previous gastrectomy with Billroth II or Roux-en-Y reconstruction. 5. In patients with acute pancreatitis 6. In patients with impacted stone or tumor of ampulla of Vater. 7. In patients with bilioduodenal fistula opening around the papilla |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kitano Hospital, The Tazuke Kofukai Medical Research Institute | ||||||
Division name | Division of Gastroenterology and Hepatology, Digestive Disease Center | ||||||
Zip code | |||||||
Address | 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan | ||||||
TEL | 06-6312-8831 | ||||||
kuritaaki1976@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Kitano Hospital, The Tazuke Kofukai Medical Research Institute | ||||||
Division name | Division of Gastroenterology and Hepatology, Digestive Disease Center | ||||||
Zip code | |||||||
Address | 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan | ||||||
TEL | 06-6312-8831 | ||||||
Homepage URL | |||||||
kuritaaki1976@gmail.com |
Sponsor | |
Institute | Kitano Hospital, The Tazuke Kofukai Medical Research Institute |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | None |
Name of secondary funder(s) | None |
IRB Contact (For public release) | |
Organization | |
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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 | 田附興風会医学研究所北野病院(大阪府) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
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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=R000020629 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |