Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

NCT01132755 | Completed Phase 2 Results

• 1 other identifier: 10-011
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

gastric; pancreas; laparoscopy; peritoneal lavage; 10-011; gastric and pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.

  2 years

Study Arms (1)

Patients who require diagnostic laparoscopy

EXPERIMENTAL

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

Interventions

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.

Also known as: 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.

Patients who require diagnostic laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Interventions

Peritoneal Lavage; Therapeutic Irrigation; Fluid Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Drug Therapy

Results Point of Contact

• Title: Dr. Peter Kingham MD
• Organization: Memorial Sloan Kettering Cancer Center

kinghamt@mskcc.org

212-639-5260

Study Officials

• T. Peter Kingham, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2017-08

Locations

US (1)