Pancreatic CancerEarly Phase 1NCT00427752
Abdominal Exploration Without Incisions
A Early Phase 1 study testing Transgastric endoscopic peritoneoscopy. in people with Pancreatic Cancer, run by Jeffrey Hazey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Transgastric endoscopic peritoneoscopy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic Cancer undergoing staging laparoscopy
- Staging or diagnostic laparoscopy in anyone needing enteral access
Who cannot join
- Lack of consent
- Intra-abdominal adhesions precluding diagnostic laparoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Center for Minimally Invasive Surgery
Columbus, Ohio, 43210
About this study
Official title: Diagnostic Transluminal Endoscopic Peritoneoscopy
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Transgastric endoscopic peritoneoscopy.
- Keywords
- Transgastric, Endoluminal, Peritoneoscopy, Diagnostic, Feasibility
- Medical subject headings
- Pancreatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgastric endoscopic peritoneoscopy.Procedure or surgery
Exploration of the abdominal area
| Study group | Role | What they receive |
|---|---|---|
| Whipple | Experimental | Patients with pancreatic cancer who will proceed to a Whipple procedure. Receives: Procedure: Transgastric endoscopic peritoneoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) That transgastric endoscopic peritoneoscopy is feasible.
Measured: 4/12
Secondary outcomes (1)
That bacterial abdominal contamination is not clinically significant.
Measured: 04/11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Hazey
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic, Ethicon Endo-Surgery
- Responsible party
- Sponsor-investigator, Jeffrey Hazey, Ohio State University
- Investigators
- Jeffrey W Hazey, MD, Principal investigator, Ohio State UniversityWilliam S Melvin, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427752
- Sponsor's protocol ID
- 2006H0120
- Status last verified
- May 2012
- First submitted
- 25 Jan 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18027034Cios 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.
PubMed 17710490Hazey 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.
PubMed 17054006Malik 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.
PubMed 16865615Hazey 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.
PubMed 17701250
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Transluminal Endoscopic Peritoneoscopy
- ClinicalTrials.gov ID
- NCT00427752
- Acronym / sponsor ID
- 2006H0120
- Conditions
- Pancreatic Cancer
- Keywords
- Transgastric, Endoluminal, Peritoneoscopy, Diagnostic, Feasibility
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jeffrey HazeyUniversity, hospital or other
- Collaborators
- Stryker Nordic, Ethicon Endo-Surgery
- Study start
- Oct 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whipple | Experimental | Procedure: Transgastric endoscopic peritoneoscopy.Patients with pancreatic cancer who will proceed to a Whipple procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pancreatic Cancer undergoing staging laparoscopy
- Staging or diagnostic laparoscopy in anyone needing enteral access
Key exclusion criteria (2 listed)
- Lack of consent
- Intra-abdominal adhesions precluding diagnostic laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transgastric endoscopic peritoneoscopy.Exploration of the abdominal area | Procedure or surgery | Whipple |
Primary outcome
1) That transgastric endoscopic peritoneoscopy is feasible.
Time frame: 4/12
1 secondary outcome
That bacterial abdominal contamination is not clinically significant.
Time frame: 04/11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
- Background: PubMed 18027034Narula 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.
- Background: PubMed 17710490Cios 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.
- Background: PubMed 17054006Hazey 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.
- Background: PubMed 16865615Malik 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.
- Results publication: PubMed 17701250Hazey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey W Hazey, MD principal investigator
Ohio State University
William S Melvin, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transgastric endoscopic peritoneoscopy. in people with Pancreatic Cancer, run by Jeffrey Hazey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) That transgastric endoscopic peritoneoscopy is feasible. (time frame: 4/12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427752, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012; AzTrials last refreshed its copy on 29 Oct 2026.