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Background
Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
Design
- Prospective randomized trial.
Setting:
- Tertiary-care medical center
Patients
- This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loop guidewire | Active Comparator | This study has two arms. We will compare the performance of a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation with loop guidewire. |
|
| Straight guidewire | Active Comparator | This study has two arms. We will compare the performance of a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation with straight guidewire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biliary cannulation with loop guidewire | Device | Selective biliary cannulation during endoscopic retrograde cholangiopancreatography |
|
| Measure | Description | Time Frame |
|---|---|---|
| The cannulation success rate | Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30). |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of the cannulation, immediate and late complications. | Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung Moo Yoo, MD, PhD | Department of Gastroenterology, Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Ajou University School of Medicine | Suwon | Gyeonggi-do | 443-721 | South Korea |
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D001650 | Bile Duct Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Biliary cannulation with straight guidewire | Device | Selective biliary cannulation during endoscopic retrograde cholangiopancreatography |
|
| D002769 | Cholelithiasis |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |