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Pancreatic Head MassNCT00816179

Diagnostic Endoscopic Exploration for Pancreatic Head Mass

A study testing Transgastric diagnostic endoscopic peritoneoscopy in people with Pancreatic Head Mass, run by Jeffrey Hazey at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly 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 Head Mass
What is being tested?
Transgastric diagnostic endoscopic peritoneoscopy
Type of treatment
Surgery or procedure
How many people
11 participants
Where
1 siteUnited States
Study dates
Jul 2008to Aug 2014
Phase
Interventional
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

  • Age range 18-80
  • Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma

Who cannot join

  • Inability to obtain informed consent
  • Pregnancy
  • Intra-abdominal adhesions that preclude endoscopy
  • Contraindication to upper endoscopy such as stricture, stenosis of the foregut
  • Previous gastric surgery
  • Diagnosis of pancreatic body or tail tumor
Show all 11Show fewer
  • History or current diagnosis of gastric ulcer
  • Metastatic disease diagnosed by CT, EUS, MRI, or nuclear imaging
  • Patient is not a candidate for resection based upon CT, EUS, MRI, or nuclear imaging
  • Antiplatelet medication not stopped at least 7 days prior to procedure
  • Anticoagulant medication not stopped at least 5 days prior to procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Human Clinical Trial of Diagnostic Transgastric Endoscopic Peritoneoscopy for Staging of Pancreatic Head Mass

This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed.

Read the detailed description

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

Being tested
Transgastric diagnostic endoscopic peritoneoscopy
Keywords
Pancreatic head mass, Pancreatic cancer, NOTES, Endoscopic peritoneoscopy, Whipple, palliative gastrojejunostomy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transgastric diagnostic endoscopic peritoneoscopyProcedure or surgery

    Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment.

    Measured: Intraoperatively

Secondary outcomes (2)

  1. Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration.

    Measured: 1 year

  2. Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures.

    Measured: Intraoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionAug 2014
  4. Study completionAug 2014

Why it stopped: Helical CT scans at our institution preclude the necessity for diagnostic laparoscopy in most cases at our institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00816179
Sponsor's protocol ID
2007C0086
Status last verified
Oct 2014
First submitted
30 Dec 2008
Last updated
3 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33. doi: 10.1007/s00464-005-3006-0. No abstract available.

    PubMed 16402290

  • White R, Winston C, Gonen M, D'Angelica M, Jarnagin W, Fong Y, Conlon K, Brennan M, Allen P. Current utility of staging laparoscopy for pancreatic and peripancreatic neoplasms. J Am Coll Surg. 2008 Mar;206(3):445-50. doi: 10.1016/j.jamcollsurg.2007.09.021. Epub 2007 Nov 26.

    PubMed 18308214

  • Lillemoe KD, Cameron JL, Hardacre JM, Sohn TA, Sauter PK, Coleman J, Pitt HA, Yeo CJ. Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial. Ann Surg. 1999 Sep;230(3):322-8; discussion 328-30. doi: 10.1097/00000658-199909000-00005.

    PubMed 10493479

  • Ponsky JL. Gastroenterologists as surgeons: what they need to know. Gastrointest Endosc. 2005 Mar;61(3):454. doi: 10.1016/s0016-5107(04)02632-x. No abstract available.

    PubMed 15758924

  • Wagh MS, Merrifield BF, Thompson CC. Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model. Clin Gastroenterol Hepatol. 2005 Sep;3(9):892-6. doi: 10.1016/s1542-3565(05)00296-x.

    PubMed 16234027

  • Merrifield BF, Wagh MS, Thompson CC. Peroral transgastric organ resection: a feasibility study in pigs. Gastrointest Endosc. 2006 Apr;63(4):693-7. doi: 10.1016/j.gie.2005.11.043.

    PubMed 16564875

  • Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004 Jul;60(1):114-7. doi: 10.1016/s0016-5107(04)01309-4.

    PubMed 15229442

  • Ikeda K, Fritscher-Ravens A, Mosse CA, Mills T, Tajiri H, Swain CP. Endoscopic full-thickness resection with sutured closure in a porcine model. Gastrointest Endosc. 2005 Jul;62(1):122-9. doi: 10.1016/s0016-5107(05)00517-1.

    PubMed 15990831

  • Onders RP, McGee MF, Marks J, Chak A, Rosen MJ, Ignagni A, Faulx A, Schomisch S, Ponsky J. Natural orifice transluminal endoscopic surgery (NOTES) as a diagnostic tool in the intensive care unit. Surg Endosc. 2007 Apr;21(4):681-3. doi: 10.1007/s00464-007-9214-z. Epub 2007 Feb 16.

    PubMed 17364154

  • Lima E, Rolanda C, Pego JM, Henriques-Coelho T, Silva D, Carvalho JL, Correia-Pinto J. Transvesical endoscopic peritoneoscopy: a novel 5 mm port for intra-abdominal scarless surgery. J Urol. 2006 Aug;176(2):802-5. doi: 10.1016/j.juro.2006.03.075.

    PubMed 16813951

  • McGee MF, Rosen MJ, Marks J, Chak A, Onders R, Faulx A, Ignagni A, Schomisch S, Ponsky J. A reliable method for monitoring intraabdominal pressure during natural orifice translumenal endoscopic surgery. Surg Endosc. 2007 Apr;21(4):672-6. doi: 10.1007/s00464-006-9124-5. Epub 2007 Feb 7.

    PubMed 17285385

  • Kantsevoy SV, Hu B, Jagannath SB, Vaughn CA, Beitler DM, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Magee CA, Pipitone LJ, Talamini MA, Kalloo AN. Transgastric endoscopic splenectomy: is it possible? Surg Endosc. 2006 Mar;20(3):522-5. doi: 10.1007/s00464-005-0263-x. Epub 2006 Jan 21.

    PubMed 16432652

  • Kantsevoy SV, Jagannath SB, Niiyama H, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Magee CA, Vaughn CA, Barlow D, Shimonaka H, Kalloo AN. Endoscopic gastrojejunostomy with survival in a porcine model. Gastrointest Endosc. 2005 Aug;62(2):287-92. doi: 10.1016/s0016-5107(05)01565-8.

    PubMed 16046997

  • Bergstrom M, Ikeda K, Swain P, Park PO. Transgastric anastomosis by using flexible endoscopy in a porcine model (with video). Gastrointest Endosc. 2006 Feb;63(2):307-12. doi: 10.1016/j.gie.2005.09.035.

    PubMed 16427940

  • Park PO, Bergstrom M, Ikeda K, Fritscher-Ravens A, Swain P. Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis (videos). Gastrointest Endosc. 2005 Apr;61(4):601-6. doi: 10.1016/s0016-5107(04)02774-9.

    PubMed 15812420

Questions about this trial

What is this clinical trial studying?

A study testing Transgastric diagnostic endoscopic peritoneoscopy in people with Pancreatic Head Mass, 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 11 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: stopped early, as of the sponsor's last update on 3 Nov 2014. 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.

Are results available for this study?

The study was stopped early (reason given: Helical CT scans at our institution preclude the necessity for diagnostic laparoscopy in most cases at our institution.). Results are not available in the source record.

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?

Endoscopically visualize the abdominal cavity to determine absence or presence of metastatic lesions to successfully stage pancreatic head malignancies and direct surgical treatment. (time frame: Intraoperatively). 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 NCT00816179, which also lists 20 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 3 Nov 2014.

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