Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Study Overview
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Brief Summary
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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.

Official Title
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Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Conditions
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Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
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* Procedure: Diagnostic peritoneal lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who require diagnostic laparoscopy<br>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 site to be left up to the individual surgeon. | Procedure: Diagnostic peritoneal lavage<br>* 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 from tenting down closer to visceral structures. Intraperitoneal placement of the catheter will be confirmed by injection of saline into the needle with no resistance and with the saline in the hub of the needle falling into the peritoneal cavity spontaneously. A guide wire will be placed through the Veress and utilizing the Seldinger technique, a 9Fr peritoneal catheter will be placed.<br>* Other names: utilized.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric, pancreas, laparoscopy, peritoneal lavage, 10-011, gastric and pancreatic cancer