Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
This trial is active, not recruiting.
|Conditions||gastric cancer, pancreatic cancer|
|Treatment||diagnostic peritoneal lavage|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||May 2010|
|End date||May 2017|
|Trial size||115 participants|
|Trial identifier||NCT01132755, 10-011|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To determine if the cytology results from percutaneous peritoneal lavage are in concordance with the cytology from laparoscopically guided peritoneal lavage.
time frame: 2 years
Percutaneous peritoneal lavage is a safe technique to utilize in place of laparoscopic lavage.
time frame: 2 years
Male or female participants at least 18 years old.
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.
|Official title||Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage|
|Principal investigator||T. Peter Kingham, MD|
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