Clinical trialPhase 2Completed
Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- May 2010
- Expected end
- 16 August 2017
- Enrollment
- 112 participants
- Sites
- 1
- Primary outcomes
- Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection
- Sponsor
- Other
- Results posted
- 2019-06-14
- Last update
- 14 June 2019
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection [2 years]. Count Of Participants, Participants. Percutaneous & laparoscopic specimen collection: Patients Who Require Diagnostic Laparoscopy (n=76): 70. Inability to access abdomen using Veress needle: Patients Who Require Diagnostic Laparoscopy (n=76): 2. Inadequate fluid return for cytology: Patients Who Require Diagnostic Laparoscopy (n=76): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Safety of Peritoneal Lavage in Place of Laparoscopic Lavage. [2 years]. Number, procedural injuries. Patients Who Require Diagnostic Laparoscopy (n=76): 0.