- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353177
Effects of HIPEC on Postoperative Bowel Motility and Complications
Effects of Hyperthermic Intraperitoneal Chemotherapy on Postoperative Bowel Motility and Complications: A Single-Center Retrospective Study
This retrospective cohort study was conducted at our institution, involving patients with gastric cancer, appendiceal mucinous neoplasm, or colon cancer who underwent CRS with or without HIPEC between January 2017 and December 2023.
Patient selection criteria would include all the following: 1) Karnofsky performance status (KPS) score >50; 2) stage T4b (American Joint Committee on Cancer [AJCC] 8th edition stage) or peritoneal metastasis was confirmed during or after surgery; 3) life expectancy >3 months; 4) peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3; and 5) acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation. The exclusion criteria were defined as follows: 1) Performance of emergency surgery due to intestinal obstruction or perforation; 2) a history of inflammatory bowel disease (IBD); 3) two or more independent surgical procedures on the gastrointestinal tract; and 4) who received postoperative enema. Patients were divided into two groups based on the treatment strategy: (1) surgery alone (No-HIPEC group); (2) surgery combined with HIPEC (HIPEC group).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Beijing, China
- Peking University People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of gastric, appendiceal, or colon malignant tumors of stage T4b or peritoneal metastases;
- Karnofsky performance status (KPS) score >50;
- Life expectancy >3 months;
- Peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3;
- Acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation.
Exclusion Criteria:
- Emergency surgery due to intestinal obstruction or perforation;
- A history of inflammatory bowel disease (IBD);
- Two or more independent surgical procedures on the gastrointestinal tract;
- Postoperative enema.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients diagnosed with PM or stage T4b who underwent surgery were included
Patient selection criteria would include all the following: 1) Karnofsky performance status (KPS) score >50; 2) stage T4b (American Joint Committee on Cancer [AJCC] 8th edition stage) or peritoneal metastasis was confirmed during or after surgery; 3) life expectancy >3 months; 4) peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3; and 5) acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation.
The exclusion criteria were defined as follows: 1) Performance of emergency surgery due to intestinal obstruction or perforation; 2) a history of inflammatory bowel disease (IBD); and 3) two or more independent surgical procedures on the gastrointestinal tract.
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Patients diagnosed with PM or stage T4b who underwent surgery combined with HIPEC
Patient selection criteria, as previously published [26], would include all the following: 1) Karnofsky performance status (KPS) score >50; 2) stage T4b (American Joint Committee on Cancer [AJCC] 8th edition stage) or peritoneal metastasis was confirmed during or after surgery; 3) life expectancy >3 months; 4) peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3; and 5) acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation.
The exclusion criteria were defined as follows: 1) Performance of emergency surgery due to intestinal obstruction or perforation; 2) a history of inflammatory bowel disease (IBD); and 3) two or more independent surgical procedures on the gastrointestinal tract.
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HIPEC was performed after gastrectomy or hemicolectomy, alimentary tract reconstruction and wound closure.
Catheters, including the inflow and outflow tubes, were crossly placed into the abdominal cavity prior to primary abdominal closure.
The temperature probes were placed on the inflow and outflow catheter tips.
HIPEC was administered for 1 hour with an automatic HIPEC device (Thermochem НТ-1000 (ThermaSolutions, Inc., USA)).
Perfusate used was Ringer's solution (5-6 L) mixed with cisplatin 50 mg/m2, 5-fluorouracil 500mg/m2 or raltitrexed 3 mg/m2, and warmed to an inflow temperature of 44 ℃.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time to first defecation after surgery
Time Frame: Perioperative
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Perioperative
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Length of postoperative stay
Time Frame: Perioperative
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Perioperative
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Incidence of postoperative complications
Time Frame: Perioperative
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Perioperative
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Collaborators and Investigators
Publications and helpful links
General Publications
- 1. Montori G, Coccolini F, Ceresoli M, Catena F, Colaianni N, Poletti E, Ansaloni L: The treatment of peritoneal carcinomatosis in advanced gastric cancer: state of the art. Int J Surg Oncol 2014, 2014:912418. 2. Zani S, Papalezova K, Stinnett S, Tyler D, Hsu D, Blazer DG, 3rd: Modest advances in survival for patients with colorectal-associated peritoneal carcinomatosis in the era of modern chemotherapy. J Surg Oncol 2013, 107(4):307-311. 3. Zhang JF, Lv L, Zhao S, Zhou Q, Jiang CG: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined with Surgery: A 12-Year Meta-Analysis of this Promising Treatment Strategy for Advanced Gastric Cancer at Different Stages. Ann Surg Oncol 2022, 29(5):3170-3186. 4. Patel M, Arora A, Mukherjee D, Mukherjee S: Effect of hyperthermic intraperitoneal chemotherapy on survival and recurrence rates in advanced gastric cancer: a systematic review and meta-analysis. Int J Surg 2023, 109(8):2435-2450. 5. Verwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA: Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol 2003, 21(20):3737-3743. 6. Verwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H: 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol 2008, 15(9):2426-2432. 7. Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F et al: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol 2009, 27(36):6237-6242.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025PHB566-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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