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Clinical Trial NCT07493876 (EPICH) for Peritoneal Carcinomatosis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC (EPICH) 300
Clinical Trial NCT07493876 (EPICH) is an interventional study for Peritoneal Carcinomatosis that is recruiting. It started on 23 January 2025 with plans to enroll 300 participants. Led by Fondazione del Piemonte per l'Oncologia, it is expected to complete by 30 December 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
This prospective multicenter interventional pre-post study aims to evaluate the effect of implementing an Enhanced Recovery After Surgery (ERAS) protocol in patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC). Approximately 300 patients will be enrolled across 20 Italian centers. During an initial pre-intervention period, usual per...Show More
Detailed Description
ERAS is a multimodal perioperative care pathway designed to reduce surgical stress and accelerate postoperative recovery through coordinated evidence-based interventions involving surgery, anesthesia, nutrition, and rehabilitation. In patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without HIPEC, postoperative morbidity and prolonged hospitalization remain clinically relevant issues. ...Show More
Official Title
Prospective Multicenter Interventional Pre-Post Study of an Enhanced Recovery After Surgery (ERAS) Protocol in the Perioperative Management of Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC (EPICH)
Conditions
Peritoneal CarcinomatosisOther Study IDs
- EPICH
- 002-FPO24
NCT ID Number
Start Date (Actual)
2025-01-23
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-12-30
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Cytoreductive Surgery
HIPEC
Enhanced Recovery After Surgery
ERAS
Peritoneal Surface Malignancies
HIPEC
Enhanced Recovery After Surgery
ERAS
Peritoneal Surface Malignancies
Primary Purpose
Supportive Care
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionUsual Perioperative Management Participants enrolled during the first study period (approximately 4 months; expected n=100) will undergo usual perioperative management for cytoreductive surgery with or without HIPEC as routinely practiced at each participating center. | N/A |
OtherERAS Perioperative Management Protocol Participants enrolled during the second study period (approximately 8 months; expected n=200) will undergo perioperative management according to a predefined ERAS protocol including preoperative counseling and prehabilitation, nutritional assessment and support, optimized fasting and carbohydrate loading, standardized antibiotic and antithrombotic prophylaxis, multimodal analgesia, goal-directed or restrictive fluid ...Show More | ERAS Perioperative Management Protocol A multimodal perioperative care pathway for patients undergoing cytoreductive surgery with or without HIPEC, implemented by a multidisciplinary ERAS team and including coordinated preoperative, intraoperative, and postoperative measures aimed at reducing surgical stress and improving recovery. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Postoperative Hospital Length of Stay | Hospital length of stay measured in days from the date of surgery (Day 0) to the date of discharge from the index hospitalization. For the primary analysis, outliers with a hospital stay greater than the 95th percentile of the distribution will be excluded | From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Adherence to Selected ERAS Protocol Items | Adherence to the predefined ERAS perioperative items selected for monitoring, assessed across the preoperative, intraoperative, and postoperative phases of care | Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery |
Incidence of Postoperative Complications | Incidence of postoperative complications defined according to the Clavien-Dindo classification. | From the date of surgery to 30 days after surgery |
Postoperative Intensive Care Unit Length of Stay | Length of postoperative intensive care unit (ICU) stay among participants admitted to the ICU after the index surgery, measured as the number of nights spent in intensive care | From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery |
Incidence of Reinterventions | Incidence of surgical reinterventions after the index procedure. | From the date of surgery to 30 days after surgery |
Incidence of Hospital Readmissions | Incidence of hospital readmissions after discharge following the index procedure. | From hospital discharge to 30 days after surgery. |
Incidence of Emergency Department Visits | Incidence of emergency department visits after the index procedure. | From hospital discharge to 30 days after surgery. |
Time to Recovery of Bowel Function | Time to recovery of bowel function, measured in days from the date of surgery to the first documented postoperative recovery of bowel function | From Day 0 (date of surgery) to first documented recovery of bowel function, assessed daily during the index hospitalization, up to 30 days after surgery |
All-Cause Mortality | Incidence of death from any cause. | From the date of surgery to 30 days after surgery. |
Quality of Postoperative Recovery | Mean quality of recovery score measured using the QoR-15 questionnaire. | Approximately 48 hours after surgery |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Written informed consent signed before the procedure
- Histological or cytological diagnosis of advanced solid tumor with documented peritoneal carcinomatosis originating from one of the following: peritoneal mesothelioma or other primary malignant peritoneal tumor, gynecologic tumor, gastric tumor, or intestinal tumor
- Age >18 years
- ECOG performance status ≤1
- ASA score ≤3
- Missing written informed consent
- ASA score ≥4
- Palliative surgery or other unplanned surgery
- Severe renal insufficiency, severe hepatic insufficiency, severe heart failure, recent myocardial infarction, or severe arrhythmia
- Immunocompromised patients, patients receiving immunosuppressive therapy, or patients with immune system diseases
Fondazione del Piemonte per l'OncologiaStudy Central Contact
Contact: Manuela Robella, MD, +390119933445, [email protected]
2 Study Locations in 1 Countries
Turin
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin, 10060, Italy
Recruiting
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Not yet recruiting