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OpenTrials
Completed

NCT Number: NCT01238341

Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).

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Key information

Conditions

Pancreatobiliary Disease Altered Gastric Anatomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands at UF Endoscoppy Center

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is 18 years or older
  • Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
  • Subject has altered gastric anatomy
  • Subject must be able to give informed consent.

Exclusion criteria

  • Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
  • The subject is unable to give informed consent

Treatment and study plan

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Procedure

An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy

Primary outcomes

  1. Papilla or Duct-enterostomy Was Reached

    Time frame: During procedure, up to 3 hours

Secondary outcomes

  1. Successful Cannulation of the Duct of Intent

    Time frame: During procedure, up to 3 hours

    Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.

  2. Successful Endoscopic Therapy

    Time frame: During procedure, up to 3 hours

  3. Total Procedure Time

    Time frame: During procedure, up to 3 hours

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2010
Registry last updated
Oct 23, 2015

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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