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Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

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ClinicalTrials.gov Identifier: NCT01132755
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

May 26, 2010
May 28, 2010
August 22, 2017
May 2010
August 16, 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01132755 on ClinicalTrials.gov Archive Site
Percutaneous peritoneal lavage is a safe technique to utilize in place of laparoscopic lavage. [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Gastric Cancer
  • Pancreatic Cancer
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 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.
Other Names:
  • 800cc of saline will be infused and 60ml will be extracted and sent to the
  • cytopathology lab. When the laparoscope is inserted for laparoscopic guided
  • lavage, no additional fluid will be instilled, unless there is no available
  • fluid in the RUQ, LUQ, and pelvic locations that are currently sampled.
  • Instead, the fluid already present from the percutaneous lavage will be
  • utilized.
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 site to be left up to the individual surgeon.
Intervention: Procedure: Diagnostic peritoneal lavage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
125
August 16, 2017
August 16, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01132755
10-011
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: T. Peter Kingham, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP