A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy
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|ClinicalTrials.gov Identifier: NCT02463877|
Recruitment Status : Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : July 5, 2019
The purpose of this study is to determine the feasibility of surgical techniques involving minimal entry into the living body approach for tumor reduction and treatment in which highly concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and to determine if this approach may improve short-term postoperative outcomes, including the development of complications related to surgery within the first 30 days after surgery.
Participation in this study is entirely voluntary. Approximately 30 subjects will take part in this single-center study and all will be enrolled at University of California San Diego.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Procedure: Minimally-Invasive Procedure||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 5, 2023|
single-arm study of laparoscopic cytoreduction and HIPEC
Procedure: Minimally-Invasive Procedure
- Rate of postoperative complications [ Time Frame: within 30 days of surgery ]Rate of postoperative complications within 30 days of surgery: this will be expressed as simple ratio with 95% confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463877
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Kaitlyn Kelly, MD||University of California, San Diego|