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Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Primary Purpose

Gastric Cancer, Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diagnostic peritoneal lavage
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring gastric, pancreas, laparoscopy, peritoneal lavage, 10-011, gastric and pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients who require diagnostic laparoscopy

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.
Safety is measured in the number of bowel, major omental, or major vascular injuries.

Full Information

First Posted
May 26, 2010
Last Updated
March 14, 2019
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01132755
Brief Title
Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Official Title
Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Pancreatic Cancer
Keywords
gastric, pancreas, laparoscopy, peritoneal lavage, 10-011, gastric and pancreatic cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients who require diagnostic laparoscopy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic peritoneal lavage
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.
Description
Safety is measured in the number of bowel, major omental, or major vascular injuries.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. Peter Kingham, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

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