Rapid Gastric And Pancreas Cancer Staging Utilizing Peritoneal Lavage

Study Overview

Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

This study is being done to develop a new method that can rapidly stage patients with gastric and pancreas cancer. Staging means finding out what is the extent of the cancer in a patient's body. Currently before patients have the surgery to remove their cancer, a surgical exam is done in the operating room to see if their cancer has spread. A thin tube-like instrument with lens and a light is placed into the abdomen. This is done by making small cuts into the body. This exam is called a diagnostic laparoscopy. If cancer spread is not seen, fluid is put into the abdomen and then taken out. This is called "lavage" or washing. The fluid is then looked at in a laboratory. If the fluid contains cancer cells surgery is often delayed. The investigators are testing a new method to put the fluid into the abdomen. It is called percutaneous lavage. Percutaneous means "through the skin". A needle is put through the skin into the abdomen. Tubing is then placed over the needle so that fluid can be put into the abdomen and then taken out. The fluid is then looked at in a laboratory. The investigators want to see if the two methods are equal because if they are equal, in the future, patients may be able to have this procedure done outside of the operating room.

N/A

Gastric Cancer
Pancreatic Cancer

PROCEDURE: Diagnostic peritoneal lavage

10-011

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-05-26	Results First Submitted 2018-03-12	Last Update Submitted that met QC Criteria 2019-03-14
First Submitted that Met QC Criteria 2010-05-27	Results First Submitted that Met QC Criteria 2019-03-14	Last Update Posted (ACTUAL) 2019-06-14
First Posted (ACTUAL) 2010-05-28	Results First Posted 2019-06-14	Last Verified 2017-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Patients who require diagnostic laparoscopy Diagnostic peritoneal lavage will be performed at the time of laparoscopy utilizing a Veress needle/Seldinger technique to insert a peritoneal dialysis catheter. This is not a new technique. The Veress needle will be inserted in the abdominal wall, at a s	PROCEDURE: Diagnostic peritoneal lavage The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon. Caudal traction will be applied to the abdominal wall to provide a firm abdominal wall to insert the needle through, minimizing the peritoneum fro

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Patients who require diagnostic laparoscopy

Diagnostic peritoneal lavage will be performed at the time of laparoscopy utilizing a Veress needle/Seldinger technique to insert a peritoneal dialysis catheter. This is not a new technique. The Veress needle will be inserted in the abdominal wall, at a s

PROCEDURE: Diagnostic peritoneal lavage

The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon. Caudal traction will be applied to the abdominal wall to provide a firm abdominal wall to insert the needle through, minimizing the peritoneum fro

Primary Outcome Measures	Measure Description	Time Frame
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection	Cytology will be performed to compare percutaneous and laparoscopic lavage results in order to determine if percutaneous lavage specimen collection is concordant with laparoscopic lavage results	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.	Safety is measured in the number of bowel, major omental, or major vascular injuries.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Men and women 18 years of age and older
Informed consent in keeping with the policies of Memorial Sloan-Kettering Cancer Center
Presentation of gastric or pancreatic cancer based on objective findings by either:

CT scan
Endoscopy
Pathologic examination
Candidate for surgical treatment and are scheduled for laparoscopy with peritoneal lavage.

Under 18 years of age
Inability to speak or read English, and an appropriate translator is not identifiable
Unable or unwilling to give informed consent
Patients with synchronous cancers of other abdominal organs
Multiple prior surgical procedures on the abdomen where the surgeon feels that percutaneous lavage may be dangerous.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: T. Peter Kingham, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record