Gastric Cancer, Pancreatic Cancer
Conditions
Keywords
gastric, pancreas, laparoscopy, peritoneal lavage, 10-011, gastric and pancreatic cancer
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.
Interventions
PROCEDUREDiagnostic 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of Peritoneal Lavage in Place of Laparoscopic Lavage. | 2 years | Safety is measured in the number of bowel, major omental, or major vascular injuries. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Procedure not done due to medical reason | 23 |
| Overall Study | Protocol Violation | 15 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Patients Who Require Diagnostic Laparoscopy |
|---|---|
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment United States | 112 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 73 / 115 |
| other Total, other adverse events | 0 / 115 |
| serious Total, serious adverse events | 0 / 115 |
Outcome results
Primary
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
Time frame: 2 years
Population: 76 participants underwent percutaneous and laparoscopic lavage
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Require Diagnostic Laparoscopy | Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection | Percutaneous & laparoscopic specimen collection | 70 Participants |
| Patients Who Require Diagnostic Laparoscopy | Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection | Inability to access abdomen using Veress needle | 2 Participants |
| Patients Who Require Diagnostic Laparoscopy | Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection | Inadequate fluid return for cytology | 4 Participants |
Secondary
Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.
Safety is measured in the number of bowel, major omental, or major vascular injuries.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Require Diagnostic Laparoscopy | Safety of Peritoneal Lavage in Place of Laparoscopic Lavage. | 0 procedural injuries |