Overview

This trial is active, not recruiting.

Conditions gastric cancer, pancreatic cancer
Treatment diagnostic peritoneal lavage
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date May 2010
End date May 2017
Trial size 115 participants
Trial identifier NCT01132755, 10-011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
diagnostic peritoneal lavage 800cc of saline will be infused and 60ml will be extracted and sent to the
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Percutaneous peritoneal lavage is a safe technique to utilize in place of laparoscopic lavage.
time frame: 2 years

Eligibility Criteria

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.

Additional Information

Official title Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Principal investigator T. Peter Kingham, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.