Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Pancreatic Cancer Clinical Trial

Official title:

Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132755
• Other study ID #: 10-011
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: August 16, 2017

Study information

• Verified date: August 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection	Cytology will be performed to compare percutaneous and laparoscopic lavage results in order to determine if percutaneous lavage specimen collection is concordant with laparoscopic lavage results	2 years
Secondary	Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.	Safety is measured in the number of bowel, major omental, or major vascular injuries.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center