Diagnostic Endoscopic Exploration for Pancreatic Head Mass

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816179

Enrollment

Registered

2008-12-31

Start date

2008-07-31

Completion date

2014-08-31

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Head Mass

Keywords

Pancreatic head mass, Pancreatic cancer, NOTES, Endoscopic peritoneoscopy, Whipple, palliative gastrojejunostomy

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.

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.

Interventions

PROCEDURETransgastric diagnostic endoscopic peritoneoscopy

Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026