Development and Validation of a Prediction Model for AKI Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer

NCT ID: NCT06697613

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2024-08-31

Brief Summary

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Ovarian cancer is the most lethal malignant tumor of the female reproductive system. Cytoreduction surgery(CRS) combined with chemotherapy is the primary method for treating ovarian cancer, and complete tumor resection is an important means to improve prognosis. It has been demonstrated that the use of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) following CRS can significantly improve the prognosis of some patients with ovarian cancer. However, HIPEC with cisplatin can lead to acute kidney injury (AKI), a serious complication that can seriously affect the patient's short- and long-term prognosis. NCCN guidelines recommend the use of sodium thiosulfate in all patients receiving HIPEC. This study intends to retrospectively collect clinical characteristics of patients to establish a prediction model for kidney injury, with a view to screening those at high risk of kidney injury for use of sodium thiosulfate for nephrotoxicity rescue in cisplatin HIPEC.

Detailed Description

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Conditions

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Ovarian Cancer AKI - Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CRS-HIPEC

Hyperthermic intraperitoneal chemotherapy

Intervention Type PROCEDURE

Patients diagnosed with FIGO Stage 3 or stage 4 ovarian cancer received hyperthermic intraperitoneal chemotherapy with cisplatin following cytoreductive surgery including primary debulking surgery, interval debulking surgery and secondary debulking surgery.

Interventions

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Hyperthermic intraperitoneal chemotherapy

Patients diagnosed with FIGO Stage 3 or stage 4 ovarian cancer received hyperthermic intraperitoneal chemotherapy with cisplatin following cytoreductive surgery including primary debulking surgery, interval debulking surgery and secondary debulking surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who received HIPEC with cisplatin following cytoreductive surgery.
* Patients diagnosed with ovarian cancer pathologically.
* FIGO stage III-IV.

Exclusion Criteria

* Use of renal protective drugs such as sodium perthiosulfate.
* Any grade of chronic or acute renal disease or other serious complications existed before HIPEC.
* Patients with single kidney.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Jing Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Colombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062.

Reference Type BACKGROUND
PMID: 31046081 (View on PubMed)

Zivanovic O, Chi DS, Filippova O, Randall LM, Bristow RE, O'Cearbhaill RE. It's time to warm up to hyperthermic intraperitoneal chemotherapy for patients with ovarian cancer. Gynecol Oncol. 2018 Dec;151(3):555-561. doi: 10.1016/j.ygyno.2018.09.007. Epub 2018 Sep 22.

Reference Type BACKGROUND
PMID: 30249527 (View on PubMed)

Lemoine L, Sugarbaker P, Van der Speeten K. Drugs, doses, and durations of intraperitoneal chemotherapy: standardising HIPEC and EPIC for colorectal, appendiceal, gastric, ovarian peritoneal surface malignancies and peritoneal mesothelioma. Int J Hyperthermia. 2017 Aug;33(5):582-592. doi: 10.1080/02656736.2017.1291999.

Reference Type BACKGROUND
PMID: 28540826 (View on PubMed)

Hod T, Freedberg KJ, Motwani SS, Chen M, Frendl G, Leaf DE, Gupta S, Mothi SS, Richards WG, Bueno R, Waikar SS. Acute kidney injury after cytoreductive surgery and hyperthermic intraoperative cisplatin chemotherapy for malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2021 Apr;161(4):1510-1518. doi: 10.1016/j.jtcvs.2020.05.033. Epub 2020 May 29.

Reference Type BACKGROUND
PMID: 32631662 (View on PubMed)

Other Identifiers

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SYSKY-2024-959-01

Identifier Type: -

Identifier Source: org_study_id

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