Laparoscopy-assisted ERCP in Patients With Altered Gastri... | NCT01620632

Studies
Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

NCT01620632

Sponsor

University of Florida

Status

Completed

Last Update Posted

Jul 9, 2018Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Biliary Disease
Pancreas Disease

Interventions

Laparoscopy assisted ERCP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
511-2011	Other Identifier	UF IRB

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2, 2018Actual

Completion Date

Jul 2, 2018Actual

First Submitted Date

Jun 13, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2018

Last Update Posted Date

Jul 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Altered gastric anatomy		Patients who have an altered gastric who need an ERCP	Procedure: Laparoscopy assisted ERCP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopy assisted ERCP	Procedure	Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.	Altered gastric anatomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patients with altered gastric anatomy who need an ERCP		approximately one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter V Draganov, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shands at the University of Florida		Gainesville	Florida	32610	United States

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases
D010182	Pancreatic Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002760	Cholangiopancreatography, Endoscopic Retrograde
D010535	Laparoscopy

Ancestor Terms

ID	Term
D002758	Cholangiography
D011860	Radiography, Abdominal
D011859	Radiography
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided