Diagnostic Endoscopic Exploration for Pancreatic Head Mass

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Head Mass

Intervention / Treatment
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* Procedure: Transgastric diagnostic endoscopic peritoneoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 18-80 Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transgastric diagnostic endoscopic peritoneoscopy|Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of laparoscopic exploration (retrospectively) to endoscopic exploration. |  | 1 year | 
| Ability to obtain peritoneal biopsies when appropriate during transgastric endoscopic procedures. |  | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic head mass, Pancreatic cancer, NOTES, Endoscopic peritoneoscopy, Whipple, palliative gastrojejunostomy