Abdominal Exploration Without Incisions | NCT00427752

Studies
Abdominal Exploration Without Incisions

NCT00427752

Sponsor

Jeffrey Hazey

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

20Actual

Phase

Early Phase 1

Conditions

Pancreatic Cancer

Interventions

Transgastric endoscopic peritoneoscopy.

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

Status Module

Record Verification Date

May 2012

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

Oct 2006

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jan 25, 2007

First Submission Date that Met QC Criteria

Jan 26, 2007

First Posted Date

Jan 29, 2007Estimated

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

May 3, 2012

Last Update Posted Date

May 7, 2012Estimated

Name	Class
Stryker Nordic	INDUSTRY
Ethicon Endo-Surgery	INDUSTRY

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

This study is being conducted to determine whether an endoscope, (a small, flexible tube with a camera mounted on the end) passed down through the throat, through the stomach, and into the abdomen can safely and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient as the laparoscopic diagnostic route, which is currently the standard of care.

Detailed Description

We propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a concurrent gastrotomy for placement of a PEG, gastrojejunostomy or gastric resection.

We hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate visualization of the abdominal cavity to direct clinical treatment.

Design Module

Study Type

Interventional

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Whipple	Experimental	Patients with pancreatic cancer who will proceed to a Whipple procedure.	Procedure: Transgastric endoscopic peritoneoscopy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transgastric endoscopic peritoneoscopy.	Procedure	Exploration of the abdominal area	Whipple

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1) That transgastric endoscopic peritoneoscopy is feasible.		4/12

Secondary Outcomes

Measure	Description	Time Frame
That bacterial abdominal contamination is not clinically significant.		04/11

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pancreatic Cancer undergoing staging laparoscopy
Staging or diagnostic laparoscopy in anyone needing enteral access

Exclusion Criteria:

Lack of consent
Intra-abdominal adhesions precluding diagnostic laparoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey W Hazey, MD	Ohio State University	Principal Investigator
William S Melvin, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Center for Minimally Invasive Surgery		Columbus	Ohio	43210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18027034	Background	Narula VK, Hazey JW, Renton DB, Reavis KM, Paul CM, Hinshaw KE, Needleman BJ, Mikami DJ, Ellison EC, Melvin WS. Transgastric instrumentation and bacterial contamination of the peritoneal cavity. Surg Endosc. 2008 Mar;22(3):605-11. doi: 10.1007/s00464-007-9661-6. Epub 2007 Nov 20.
17710490	Background	Cios TJ, Reavis KM, Renton DR, Hazey JW, Mikami DJ, Narula VK, Allemang MT, Davis SS, Melvin WS. Gastrotomy closure using bioabsorbable plugs in a canine model. Surg Endosc. 2008 Apr;22(4):961-6. doi: 10.1007/s00464-007-9530-3. Epub 2007 Aug 19.

ID	Term
D010190	Pancreatic Neoplasms
D004194	Disease

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms