Clinical trial · Interventional
A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally-Invasive Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Minimally-Invasive Procedure
- description
- single-arm study of laparoscopic cytoreduction and HIPEC
- interventionNames
- Procedure: Minimally-Invasive Procedure
Primary outcomes (1)
- measure
- Rate of postoperative complications
- timeFrame
- within 30 days of surgery
- description
- Rate of postoperative complications within 30 days of surgery: this will be expressed as simple ratio with 95% confidence intervals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged \> 18 years old 2. Capable of providing informed consent. 3. Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases. 4. Evidence of low-volume peritoneal disease defined by a PCI \< 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings. 5. Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2. 6. Patients who are medically fit for surgery defined as the following: * No parenchymal hepatic metastases * No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction * No cross sectional imaging findings indicative of multi-segmental (\>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity * No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis * Absolute neutrophil count (ANC) \> 1200/mm3, white blood cell count (WBC) \> 4000/mm3 and platelet count \> 150,000/mm3 * An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible). * Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin \> 1.5 mg/dL eligible only with Gilbert's syndrome); * Alkaline phosphatase \< 2.5 times the upper limit of normal; and/or * Aspartate transaminase (AST) \< 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal) * Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits * Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery). * No clinical history of acute myocardial infarction within six months of registration. * Patients who are status post revascularization procedures with satisfactory cardiac function are eligible. * No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease. 7. No concurrent second malignancy requiring systemic therapy. 8. No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements. Exclusion Criteria: 1. Peritoneal carcinomatosis index (PCI) \> 10 2. Systemic (extraperitoneal) disease, pregnant, incarcerated. 3. Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy.
References
Publications (1)
- DERIVEDCho CY, Veerapong J, Baumgartner JM, Murphy JD, Lowy AM, Kelly KJ. Laparoscopic cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a prospective clinical trial and comparative analysis. Surg Endosc. 2023 Jul;37(7):5644-5651. doi: 10.1007/s00464-022-09589-w. Epub 2022 Dec 7. PMID 36477643