Pancreatic Cancer
Conditions
Keywords
Transgastric, Endoluminal, Peritoneoscopy, Diagnostic, Feasibility
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.
Interventions
PROCEDURETransgastric endoscopic peritoneoscopy.
Exploration of the abdominal area
Sponsors
Stryker Nordic
Ethicon Endo-Surgery
Jeffrey Hazey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) That transgastric endoscopic peritoneoscopy is feasible. | 4/12 |
Secondary
| Measure | Time frame |
|---|---|
| That bacterial abdominal contamination is not clinically significant. | 04/11 |
Countries
United States
Outcome results
None listed