Clinical trial NCT01132755: Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Official title: Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Pancreatic Cancer
Keywords: gastric
pancreas
laparoscopy
peritoneal lavage
10-011
gastric and pancreatic cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection
timeFrame: 2 years
Secondary outcomes:
measure: Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: T. Peter Kingham, MD
role: PRINCIPAL_INVESTIGATOR
References: