Trial Outcomes & Findings for Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage (NCT NCT01132755)

NCT ID: NCT01132755

Last Updated: 2019-06-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 112 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-06-14

Participant Flow

Participant milestones

Measure	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. Diagnostic 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.
Overall Study STARTED	112
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Measure	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. Diagnostic 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.
Overall Study Procedure not done due to medical reason	23
Overall Study Protocol Violation	15
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage

Baseline characteristics by cohort

Measure	Patients Who Require Diagnostic Laparoscopy n=112 Participants 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.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 76 participants underwent percutaneous and laparoscopic lavage

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

Outcome measures

Measure	Patients Who Require Diagnostic Laparoscopy n=76 Participants 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.
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection Percutaneous & laparoscopic specimen collection	70 Participants
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection Inability to access abdomen using Veress needle	2 Participants
Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection Inadequate fluid return for cytology	4 Participants

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures

Measure	Patients Who Require Diagnostic Laparoscopy n=76 Participants 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.
Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.	0 procedural injuries

Adverse Events

Patients Who Require Diagnostic Laparoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 73 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Kingham MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-5260

Email: kinghamt@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place