NCT00816179

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

6.1 years

First QC Date

December 30, 2008

Last Update Submit

October 30, 2014

Conditions

Pancreatic Head Mass

Keywords

Pancreatic head massPancreatic cancerNOTESEndoscopic peritoneoscopyWhipplepalliative gastrojejunostomy

Outcome Measures

Primary Outcomes (1)

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

    Intraoperatively

Secondary Outcomes (2)

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

    1 year

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

    Intraoperatively

Interventions

Transgastric diagnostic endoscopic peritoneoscopyPROCEDURE

Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (20)

  • 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.

    PMID: 16402290BACKGROUND

  • 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.

    PMID: 18308214BACKGROUND

  • 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.

    PMID: 10493479BACKGROUND

  • 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.

    PMID: 15758924BACKGROUND

  • 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.

    PMID: 16234027BACKGROUND

  • 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.

    PMID: 16564875BACKGROUND

  • 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.

    PMID: 15229442BACKGROUND

  • 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.

    PMID: 15990831BACKGROUND

  • 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.

    PMID: 17364154BACKGROUND

  • 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.

    PMID: 16813951BACKGROUND

  • 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.

    PMID: 17285385BACKGROUND

  • 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.

    PMID: 16432652BACKGROUND

  • 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.

    PMID: 16046997BACKGROUND

  • 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.

    PMID: 16427940BACKGROUND

  • 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.

    PMID: 15812420BACKGROUND

  • Pai RD, Fong DG, Bundga ME, Odze RD, Rattner DW, Thompson CC. Transcolonic endoscopic cholecystectomy: a NOTES survival study in a porcine model (with video). Gastrointest Endosc. 2006 Sep;64(3):428-34. doi: 10.1016/j.gie.2006.06.079.

    PMID: 16923495BACKGROUND

  • Jagannath SB, Kantsevoy SV, Vaughn CA, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Scorpio DG, Magee CA, Pipitone LJ, Kalloo AN. Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model. Gastrointest Endosc. 2005 Mar;61(3):449-53. doi: 10.1016/s0016-5107(04)02828-7.

    PMID: 15758923BACKGROUND

  • Wagh MS, Merrifield BF, Thompson CC. Survival studies after endoscopic transgastric oophorectomy and tubectomy in a porcine model. Gastrointest Endosc. 2006 Mar;63(3):473-8. doi: 10.1016/j.gie.2005.06.045.

    PMID: 16500399BACKGROUND

  • Sclabas GM, Swain P, Swanstrom LL. Endoluminal methods for gastrotomy closure in natural orifice transenteric surgery (NOTES). Surg Innov. 2006 Mar;13(1):23-30. doi: 10.1177/155335060601300105.

    PMID: 16708152BACKGROUND

  • Ko CW, Kalloo AN. Per-oral transgastric abdominal surgery. Chin J Dig Dis. 2006;7(2):67-70. doi: 10.1111/j.1443-9573.2006.00256.x.

    PMID: 16643332BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jeffrey W Hazey, MD

    OSUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 30, 2008

First Posted

December 31, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

US(1)