Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Pancreatic Cancer

Treatments: Procedure: Diagnostic peritoneal lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT01132755

10-011

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Patients who require diagnostic laparoscopy

Experimental group

Description:

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.

Treatment:

Procedure: Diagnostic peritoneal lavage