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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000016886 |
Receipt No. | R000019187 |
Scientific Title | Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2016/07/19 |
Basic information | ||
Public title | Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture | |
Acronym | Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture | |
Scientific Title | Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture | |
Scientific Title:Acronym | Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture | |
Region |
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Condition | ||
Condition | Malignant bile duct stricture | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | evaluate the usefulness of a diagnostic approach using ERCP-guided transpapillary forceps biopsy (TPB) or EUS-guided fine needle aspiration biopsy (EUS-FNAB) according to the characteristics of the strictured segment in patients with suspected MBS. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | the accuracy of the diagnostic approach using ERCP-guided TPB and EUS-FNAB according to the type of biliary stricture in patients with suspected MBS |
Key secondary outcomes | the accuracy of initial TPB, technical failure and adverse event rates of ERCP-guided TPB and EUS-FNAB |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | EUS-guided fine-needle aspiration biopsy | |
Interventions/Control_2 | Transpapillary forceps biopsy | |
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) the presence of biliary stricture due to a thickened bile duct wall or pancreatobiliary mass revealed by cross-sectional radiologic images, computed tomography (CT), and/or magnetic resonance imaging (MRI), (2) clinical findings of obstructive jaundice and/or cholangitis, (3) age >18 years, and (4) ability to provide informed consent. | |||
Key exclusion criteria | (1) underlying pancreatobiliary disease without clinical findings suggestive of malignancy (e.g., primary biliary cirrhosis or postoperative biliary stricture), (2) the presence of any contraindication for ERCP, (3) coagulopathy (international normalized ratio >1.5 or platelet count <80,000/mm3 (4) difficulty to perform ERCP due to altered gastrointestinal anatomy or a significant duodenal obstruction. | |||
Target sample size | 174 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Digestive Disease Center and Research Institute, Department of Internal Medicine, Soon Chun Hyang University School of Medicine | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea | ||||||
TEL | +82-32-621-5094 | ||||||
jhmoon@schmc.ac.kr |
Public contact | |||||||
Name of contact person |
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Organization | Department of Internal Medicine, Soon Chun Hyang University School of Medicine | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma | ||||||
TEL | +82-32-621-5094 | ||||||
Homepage URL | |||||||
joseph@schmc.ac.kr |
Sponsor | |
Institute | SoonChunHyang University |
Institute | |
Department |
Funding Source | |
Organization | SoonChunHyang University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 |
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Institutions |
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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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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=R000019187 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |