NCT01620632

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

6.6 years

First QC Date

June 13, 2012

Last Update Submit

July 5, 2018

Conditions

Biliary DiseasePancreas Disease

Keywords

laparoscopy assisted ERCPaltered gastric anatomy

Outcome Measures

Primary Outcomes (1)

  • patients with altered gastric anatomy who need an ERCP

    approximately one week

Study Arms (1)

Altered gastric anatomy

Patients who have an altered gastric who need an ERCP

Procedure: Laparoscopy assisted ERCP

Interventions

Laparoscopy assisted ERCPPROCEDURE

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

Also known as: Endoscopic Retrograde Cholangiopancreatography (ERCP), Roux-en-Y gastric bypass surgery, Laparoscopy
Altered gastric anatomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those patients who have altered gastric anatomy that require a laparoscopy assisted ERCP

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Gallbladder DiseasesPancreatic Diseases

Interventions

Cholangiopancreatography, Endoscopic RetrogradeLaparoscopy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Peter V Draganov, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

December 1, 2011

Primary Completion

July 2, 2018

Study Completion

July 2, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations

US(1)