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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Pancreatic Cancer
• Intervention / Treatment: Procedure: Diagnostic peritoneal lavage

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pancreas; laparoscopy; gastric; peritoneal lavage; 10-011; gastric and pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 10-011