Clinical Research Directory

Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases

Colorectal cancer is the second leading cause of cancer death in France, with close to 50,000 new cases each year. About half of the patients develop liver, lung and/or peritoneal metastases during the course of the disease.Peritoneal involvement, which accounts for approximately 8,000 new cases per year, carries the poorest prognosis, notably because of its chemoresistance.For patients with resectable colorectal peritoneal metastases,recommended optimal management combines systemic chemotherapy with complete cytoreductive surgery(CRS)in an expert center.Hyperthermic IntraPeritoneal Chemotherapy(HIPEC)may be added to CRS to eradicate residual microscopic disease and potentially improve survival.Clinical evidence on HIPEC for colorectal peritoneal carcinomatosis is heterogeneous and dominated by a randomized trial reporting no survival benefit and increased morbidity, results attributed to the oxaliplatin-based HIPEC regimen used. A separate body of evidence suggests a benefit of mitomycin-C-based HIPEC, with manageable morbidity and preserved quality of life. National and international guidelines therefore allow mitomycin-C HIPEC, but the procedure remains controversial: according to French hospital discharge data, about half of the patients treated for colorectal peritoneal carcinomatosis receive CRS plus HIPEC and the other half CRS alone.HIPEC also raises funding and efficiency issues. No specific French diagnosis-related tariff (GHS)exists for CRS plus HIPEC, whereas the procedure is costly in terms of operating time,human and material resources, and is associated with prolonged hospital stays and complications. To date, no prospective comparative data on the efficiency of CRS plus HIPEC are available in France.ECO-CHIP is a national,multicenter, prospective, comparative,non-randomized, open, non-interventional study using a " here-elsewhere " design (French RIPH category 3). Each participating center follows its own routine practice: centers performing HIPEC treat included patients with CRS plus mitomycin-C HIPEC (innovative strategy), while centers not performing HIPEC treat included patients with CRS alone (reference strategy).No change in management, examination or procedure is imposed by the protocol.the only procedure added because of the research is the completion of self-administered questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29 and PERI-PROM) at inclusion and at months 1, 3, 6, 12, 18, 24 and 36 after cytoreductive surgery. The primary objective is to assess, from the French health care system perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System(SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity, postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life. Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival (expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone, hazard ratio 0.66) and quality-adjusted survival at an acceptable incremental cost per QALY gained. perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System (SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity,postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life. Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival(expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone,hazard ratio 0.66)and quality-adjusted survival at an acceptable incremental cost per QALY gained.A total of 398 patients 199per group are planned for inclusion in French digestive and surgical oncology departments over a 36-month enrolment period, each patient being followed for 36 months

Long-Term Quality Of Life And Symptom Assessment Among Recurrence-Free Patients Who Underwent Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

To evaluate long-term quality of life (QoL) and participant reported symptom burden in disease-free survivors who have undergone cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) at MD Anderson, with primary emphasis on overall (composite) QoL as measured by validated instruments.

Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery

The OMNI study is a clinical trial investigating whether a nutritional supplement with added Omega-3 fatty acids can improve surgical outcomes for patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is a type of cancer that affects the abdominal lining and often requires complex and extensive surgery called cytoreductive surgery (CRS). This procedure is associated with a high risk of postoperative complications, such as infections and long hospital stays. Omega-3 fatty acids are known for their anti-inflammatory and immune-modulating properties. The study's main goal is to see if a 21-day regimen of a pre-operative Omega-3 enriched oral nutritional supplement (ONS) can reduce postoperative complications, as measured by the Clavien-Dindo classification. Who can participate? The study is recruiting patients over 18 years old who have been diagnosed with non-gynecological peritoneal carcinomatosis and are scheduled to undergo cytoreductive surgery and HIPEC (hyperthermic intraperitoneal chemotherapy). What does participating involve? Upon joining the study, participants will be randomly assigned to one of two groups: * Intervention Group: Participants will receive an Omega-3 enriched nutritional supplement called Fortimel Forticare. * Control Group: Participants will receive a standard nutritional supplement called Fortimel Compact Protein. Both groups will be asked to consume two bottles of their assigned supplement per day for 21 days before the scheduled surgery. What will be measured? Throughout the study, the investigators will perform various assessments to monitor participant health and recovery: * Before and after surgery: The investigators will take body measurements, conduct a bioimpedance analysis (BIA) to check body composition, and perform a Hand Grip test to measure muscle strength. The investigators will also collect blood and stool samples. * During surgery: The investigators will collect tissue samples to study the tumor environment. * After surgery: The investigators will track patient recovery, including the length of the hospital stay and any complications that may occur. The investigators will also continue to monitor certain markers in the patients' blood. The study is expected to enroll a total of 28 patients.

Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.

Cytoreductive surgery (CRS), with or without hyperthermic intraperitoneal chemotherapy (HIPEC), is currently the standard treatment for advanced peritoneal tumors, including pseudomyxoma peritonei (PMP), colorectal, and ovarian peritoneal carcinomatosis. This complex surgical approach involves extensive resections to remove all visible tumor deposits, often followed by heated intraperitoneal chemotherapy to target residual microscopic disease. While CRS ± HIPEC has been shown to improve survival, it is associated with significant postoperative morbidity, particularly affecting the abdominal wall. One of the most frequent and clinically relevant complications is the development of ventral (incisional) hernias, which can reduce quality of life, limit physical activity, and sometimes require additional surgical repair. The incidence, risk factors, and optimal management of ventral hernias after CRS ± HIPEC remain incompletely defined. Reported incidences vary widely, likely due to differences in surgical techniques, patient populations, definitions of hernia, and follow-up duration. Known contributing factors include extensive laparotomies, multiple resections, tissue fragility induced by hyperthermic chemotherapy, and patient-specific factors such as age and body mass index. Additionally, management strategies for ventral hernias are heterogeneous, ranging from direct fascial closure to reinforcement with synthetic or biological meshes, using different surgical approaches (onlay or sublay), with limited evidence in oncologic settings. This single-center retrospective observational study at the Institut Jules Bordet aims to provide a comprehensive analysis of ventral hernia occurrence, risk factors, and management following CRS ± HIPEC. Adult patients who underwent CRS ± HIPEC for PMP, colorectal, or ovarian peritoneal carcinomatosis between January 1, 2010, and December 31, 2024, were included. Patients with prior ventral hernias, incomplete follow-up (\<12 months), missing data, or interrupted CRS due to extensive disease were excluded. Hernias were identified via clinical examination and imaging studies (CT or MRI), and classified as early (\<12 months) or late (\>12 months) postoperative events. Patients were categorized according to the presence or absence of ventral hernias at the incision site. The primary objective of the study is to determine the incidence of incisional hernias following CRS ± HIPEC. Secondary objectives include (1) identification of patient-related and surgical risk factors associated with hernia development, and (2) analysis of institutional surgical management strategies, including type of repair and timing of intervention. Data were collected retrospectively from medical records, and statistical analyses include descriptive statistics, survival analysis, and univariate and multivariate regression to identify independent risk factors for hernia development. This study is expected to provide valuable insights into the epidemiology, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, contributing to improved postoperative care, informed surgical planning, and potentially guiding institutional and international recommendations for hernia prevention and repair in this high-risk population. This study aims to provide a comprehensive understanding of the occurrence, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, which may help guide surgical practice and improve postoperative outcomes.

CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER)

Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER

HIPEC Surgery and Hemodynamics

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) involves the intraoperative administration of heated chemotherapeutic agents into the abdominal cavity following cytoreductive surgery (CRS). The increasing use of CRS combined with HIPEC has introduced certain procedural and physiological considerations that distinguish it from other surgical interventions, posing unique challenges for researchers and clinicians alike. Despite advancements in surgical and anesthetic techniques, this combined approach is frequently associated with significant hemodynamic instability, coagulation abnormalities, respiratory complications, and nutritional imbalances. The study aims to contribute to the existing body of knowledge by examining the physiological alterations induced by HIPEC, thereby offering practical insights and guidance for investigators involved in the management and study of this complex therapeutic modality.

Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy

This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.

Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI\<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.