NCT00427752

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P50-P75 for early_phase_1 pancreatic-cancer

Timeline
Completed

Started Oct 2006

Longer than P75 for early_phase_1 pancreatic-cancer

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

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

5.3 years

First QC Date

January 25, 2007

Last Update Submit

May 3, 2012

Conditions

Pancreatic Cancer

Keywords

TransgastricEndoluminalPeritoneoscopyDiagnosticFeasibility

Outcome Measures

Primary Outcomes (1)

  • 1) That transgastric endoscopic peritoneoscopy is feasible.

    4/12

Secondary Outcomes (1)

  • That bacterial abdominal contamination is not clinically significant.

    04/11

Study Arms (1)

Whipple

EXPERIMENTAL

Patients with pancreatic cancer who will proceed to a Whipple procedure.

Procedure: Transgastric endoscopic peritoneoscopy.

Interventions

Transgastric endoscopic peritoneoscopy.PROCEDURE

Exploration of the abdominal area

Whipple

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Lack of consent
  • Intra-abdominal adhesions precluding diagnostic laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Center for Minimally Invasive Surgery

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

  • 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.

    PMID: 18027034BACKGROUND

  • 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.

    PMID: 17710490BACKGROUND

  • Hazey JW, Dunkin BJ, Melvin WS. Changing attitudes toward endolumenal therapy. Surg Endosc. 2007 Mar;21(3):445-8. doi: 10.1007/s00464-006-9001-2.

    PMID: 17054006BACKGROUND

  • Malik A, Mellinger JD, Hazey JW, Dunkin BJ, MacFadyen BV Jr. Endoluminal and transluminal surgery: current status and future possibilities. Surg Endosc. 2006 Aug;20(8):1179-92. doi: 10.1007/s00464-005-0711-7. Epub 2006 Jul 24.

    PMID: 16865615BACKGROUND

  • Hazey JW, Narula VK, Renton DB, Reavis KM, Paul CM, Hinshaw KE, Muscarella P, Ellison EC, Melvin WS. Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial. Surg Endosc. 2008 Jan;22(1):16-20. doi: 10.1007/s00464-007-9548-6. Epub 2007 Aug 14.

    PMID: 17701250RESULT

MeSH Terms

Conditions

Pancreatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey W Hazey, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • William S Melvin, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

October 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

US(1)