Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer Pancreatic Cancer	Procedure: Diagnostic peritoneal lavage	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Stomach Cancer

Drug Information available for: Pancreatin Pancrelipase

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To determine if the cytology results from percutaneous peritoneal lavage are in concordance with the cytology from laparoscopically guided peritoneal lavage. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percutaneous peritoneal lavage is a safe technique to utilize in place of laparoscopic lavage. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	115
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132755

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

T. Peter Kingham, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01132755 History of Changes
Other Study ID Numbers:	10-011
Study First Received:	May 26, 2010
Last Updated:	October 10, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

gastric
pancreas
laparoscopy

peritoneal lavage
10-011
gastric and pancreatic cancer

Additional relevant MeSH terms:

Stomach Neoplasms
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013