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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic peritoneal lavage

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.

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.

Primary outcomes

Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection

Time frame: 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 outcomes

Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.

Time frame: 2 years

Safety is measured in the number of bowel, major omental, or major vascular injuries.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2017
Study completion: 2017
First posted: May 28, 2010
Registry last updated: Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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