Peritoneal CarcinomatosisEPICHNCT07493876
Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
A study testing ERAS Perioperative Management Protocol in people with Peritoneal Carcinomatosis, run by Fondazione del Piemonte per l'Oncologia at 2 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- ERAS Perioperative Management Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 23 Jan 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo
Candiolo, Turin, 10060
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
About this study
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)
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 perioperative management will be described; during a subsequent intervention period, participating centers will apply a predefined ERAS protocol. The primary objective is to assess the effect of ERAS implementation on mean postoperative hospital length of stay.
Read the detailed description
Enhanced Recovery After Surgery (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 hyperthermic intraperitoneal chemotherapy (HIPEC), postoperative morbidity and prolonged hospitalization remain clinically relevant issues. This study will evaluate the implementation of a selected ERAS protocol in this setting. The study is designed as a multicenter interventional pre-post study: during the first period (approximately 4 months; 100 patients), usual perioperative procedures will be documented; during the second period (approximately 8 months; 200 patients), centers will apply a predefined ERAS pathway. Monitored ERAS elements include prehabilitation and preoperative counseling, nutritional assessment and support, bowel preparation and antibiotic prophylaxis, perioperative fasting management, postoperative oral intake, fluid management, and intra-/postoperative analgesic management.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- ERAS Perioperative Management Protocol
- Keywords
- Cytoreductive Surgery, HIPEC, Enhanced Recovery After Surgery, ERAS, Peritoneal Surface Malignancies
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS Perioperative Management ProtocolOther
A multimodal perioperative care pathway for patients undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), implemented by a multidisciplinary Enhanced Recovery After Surgery (ERAS) team and including coordinated preoperative, intraoperative, and postoperative measures aimed at reducing surgical stress and improving recovery.
| Study group | Role | What they receive |
|---|---|---|
| Usual Perioperative Management | No intervention | Participants enrolled during the first study period (approximately 4 months; expected n=100) will undergo usual perioperative management for cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) as routinely practiced at each participating center. |
| ERAS Perioperative Management Protocol | Other | Participants enrolled during the second study period (approximately 8 months; expected n=200) will undergo perioperative management according to a predefined Enhanced Recovery After Surgery (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 therapy, early oral intake, glycemic control, early mobilization, and discharge-readiness assessment. Receives: Other: ERAS Perioperative Management Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery
Secondary outcomes (9)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: From the date of surgery to 30 days after surgery
Incidence of Hospital Readmissions
Incidence of hospital readmissions after discharge following the index procedure.
Measured: From hospital discharge to 30 days after surgery.
Incidence of Emergency Department Visits
Incidence of emergency department visits after the index procedure.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Approximately 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start23 Jan 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants enrolled during the initial pre-intervention period will receive usual perioperative management. Participants enrolled during the subsequent intervention period will receive perioperative management according to a predefined Enhanced Recovery After Surgery (ERAS) protocol.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493876
- Sponsor's protocol ID
- 002-FPO24
- Acronym
- EPICH
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07493876
- Acronym / sponsor ID
- EPICH / 002-FPO24
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- Cytoreductive Surgery, HIPEC, Enhanced Recovery After Surgery, ERAS, Peritoneal Surface Malignancies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 perioperative management will be described; during a subsequent intervention period, participating centers will apply a predefined ERAS protocol. The primary objective is to assess the effect of ERAS implementation on mean postoperative hospital length of stay.
Detailed description
Enhanced Recovery After Surgery (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 hyperthermic intraperitoneal chemotherapy (HIPEC), postoperative morbidity and prolonged hospitalization remain clinically relevant issues. This study will evaluate the implementation of a selected ERAS protocol in this setting. The study is designed as a multicenter interventional pre-post study: during the first period (approximately 4 months; 100 patients), usual perioperative procedures will be documented; during the second period (approximately 8 months; 200 patients), centers will apply a predefined ERAS pathway. Monitored ERAS elements include prehabilitation and preoperative counseling, nutritional assessment and support, bowel preparation and antibiotic prophylaxis, perioperative fasting management, postoperative oral intake, fluid management, and intra-/postoperative analgesic management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants enrolled during the initial pre-intervention period will receive usual perioperative management. Participants enrolled during the subsequent intervention period will receive perioperative management according to a predefined Enhanced Recovery After Surgery (ERAS) protocol.
| Arm | Type | Receives |
|---|---|---|
| Usual Perioperative Management | No intervention | –Participants enrolled during the first study period (approximately 4 months; expected n=100) will undergo usual perioperative management for cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) as routinely practiced at each participating center. |
| ERAS Perioperative Management Protocol | Other | Other: ERAS Perioperative Management ProtocolParticipants enrolled during the second study period (approximately 8 months; expected n=200) will undergo perioperative management according to a predefined Enhanced Recovery After Surgery (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 therapy, early oral intake, glycemic control, early mobilization, and discharge-readiness assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS Perioperative Management ProtocolA multimodal perioperative care pathway for patients undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), implemented by a multidisciplinary Enhanced Recovery After Surgery (ERAS) team and including coordinated preoperative, intraoperative, and postoperative measures aimed at reducing surgical stress and improving recovery. | Other | ERAS Perioperative Management Protocol |
Primary outcome
Postoperative Hospital Length of Stay
Time frame: From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery
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
9 secondary outcomes
Adherence to Selected ERAS Protocol Items
Time frame: 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
Time frame: From the date of surgery to 30 days after surgery
Postoperative Intensive Care Unit Length of Stay
Time frame: From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery
Incidence of Reinterventions
Time frame: From the date of surgery to 30 days after surgery
Incidence of Hospital Readmissions
Time frame: From hospital discharge to 30 days after surgery.
Incidence of Emergency Department Visits
Time frame: From hospital discharge to 30 days after surgery.
Time to Recovery of Bowel Function
Time frame: 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
Time frame: From the date of surgery to 30 days after surgery.
Quality of Postoperative Recovery
Time frame: Approximately 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Carcinomatosis
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 2
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS Perioperative Management Protocol in people with Peritoneal Carcinomatosis, run by Fondazione del Piemonte per l'Oncologia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuela Robella, MD (+390119933445, manuela.robella@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hospital Length of Stay (time frame: From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.