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Completed

NCT Number: NCT02028845

Loop-tipped Guidewire in Selective Biliary Cannulation

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.

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Key information

Conditions

Choledocholithiasis Ampullary Tumor Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Ajou University School of Medicine

Suwon, Gyeonggi-do, 443-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biliary cannulation with loop guidewire

Device

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Biliary cannulation with straight guidewire

Device

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2014
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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