Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Phase 2

Completed

• Conditions: Pancreatic Cancer; Gastric Cancer
• Interventions: Procedure: Diagnostic peritoneal lavage

• Registration Number: NCT01132755
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Status Verified: 2017-08
• Primary Completion: 2017-08-16
• Study Completion: 2017-08-16
• Results First Submitted: 2018-03-12
• Results First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Results First Posted: 2019-06-14
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients who require diagnostic laparoscopy	Diagnostic peritoneal lavage	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.

Primary Outcome Measures

Name	Time	Method
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection	2 years	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

Secondary Outcome Measures

Name	Time	Method
Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.	2 years	Safety is measured in the number of bowel, major omental, or major vascular injuries.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States