Loop-tipped Guidewire in Selective Biliary Cannulation

Pancreatic Cancer Clinical Trial

Official title:

Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028845
• Other study ID #: AJIRB-DEV-DE2-13-175
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: January 4, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ampullary Tumor
• Bile Duct Cancer
• Cholangiocarcinoma
• Choledocholithiasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Biliary cannulation with loop guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
• Biliary cannulation with straight guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Locations

Country	Name	City	State
Korea, Republic of	Department of Gastroenterology, Ajou University School of Medicine	Suwon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	Yes