Loop-tipped Guidewire in Selective Biliary Cannulation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Ajou University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Yoo Byung Moo, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT02028845
First received: December 31, 2013
Last updated: January 5, 2014
Last verified: January 2014
  Purpose
  1. Background

    • Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel.
    • The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels.
  2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
  3. Design

    - Prospective randomized trial.

  4. Setting:

    - Tertiary-care medical center

  5. Patients

    - This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.

  6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
  7. Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.

Condition Intervention
Choledocholithiasis
Bile Duct Cancer
Pancreatic Cancer
Ampullary Tumor
Device: Biliary cannulation with loop guidewire
Device: Biliary cannulation with straight guidewire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • The cannulation success rate [ Time Frame: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The duration of the cannulation, immediate and late complications. [ Time Frame: Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 192
Study Start Date: January 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Loop guidewire
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.
Device: Biliary cannulation with loop guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Active Comparator: Straight guidewire
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.
Device: Biliary cannulation with straight guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 19 and ability to consent
  • no evidence of significant cardiopulmonary or medical comorbidities precluding participation

Exclusion Criteria:

  • Known gastroduodenal anatomic abnormalities
  • Coagulation disorders (international normalized ratio > 1.5 or platelet count < 50000 cells/cubic millimeter)
  • Prior gastric surgery,endoscopic retrograde cholangiopancreatography
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028845

Contacts
Contact: Byung Moo Yoo, MD, PhD 82-31-219-5101 ext 6939 ybm6403@gmail.com

Locations
Korea, Republic of
Department of Gastroenterology, Ajou University School of Medicine Not yet recruiting
Suwon, Gyeonggi, Korea, Republic of, 443-721
Contact: Byung Moo Yoo, MD, PhD    82-31-219-5101 ext 6939    ybm6403@gmail.com   
Principal Investigator: Byung Moo Yoo, MD, PhD         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Byung Moo Yoo, MD, PhD Department of Gastroenterology, Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: Yoo Byung Moo, Assistant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02028845     History of Changes
Other Study ID Numbers: AJIRB-DEV-DE2-13-175
Study First Received: December 31, 2013
Last Updated: January 5, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Bile Duct Neoplasms
Pancreatic Neoplasms
Choledocholithiasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Cholelithiasis
Biliary Tract Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014