Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

NCT ID: NCT01132755

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2017-08-16

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.

Conditions

Gastric Cancer; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diagnostic peritoneal lavage

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention 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.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T. Peter Kingham, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

10-011

Identifier Type: -

Identifier Source: org_study_id