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OpenTrials
Completed

NCT Number: NCT01620632

Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

About this study

Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years and older
  • Altered gastric anatomy
  • Scheduled to undergo laparoscopy-assisted ERCP

Exclusion criteria

  • Any contraindications to performing endoscopy
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
  • The subject is unable/unwilling to give informed consent

Treatment and study plan

Laparoscopy assisted ERCP

Procedure

Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.

Other names: Endoscopic Retrograde Cholangiopancreatography (ERCP), Roux-en-Y gastric bypass surgery, Laparoscopy

Primary outcomes

  1. patients with altered gastric anatomy who need an ERCP

    Time frame: approximately one week

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2012
Registry last updated
Jul 9, 2018

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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