Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Condition: Gastric Cancer; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Diagnostic peritoneal lavage
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastric; pancreas; laparoscopy; peritoneal lavage; 10-011; gastric and pancreatic cancer

Summary:

      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.
    

Eligibility criteria:

        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.