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Role of Laparoscopy in Asymptomatic Patients at High Risk of Developing Colorectal Peritoneal Metastases ——A Single-center, Prospective, Exploratory Clinical Trial

Role of Laparoscopy in Asymptomatic Patients at High Risk of Developing Colorectal Peritoneal Metastases ——A Single-center, Prospective, Exploratory Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085368
Enrollment
Unknown
Registered
2024-06-06
Start date
2022-02-24
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Laparoscopy:Routine laparoscopy in patients at high risk of developing colorectal peritoneal metastases

Sponsors

Union Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects: Patients at high risk of peritoneal metastasis after radical resection of colorectal cancer (R0-R1 resection). 1) Age 18-70; 2) ASA Class I-III; 3) No distant metastasis was found in preoperative examination (except ovary); 4) There are risk factors for peritoneal metastasis, which meet one of the following conditions: simultaneous local peritoneal metastasis (resected); Simultaneous ovarian metastasis (resected); Primary perforation or intraoperative tumor rupture; pT4a/b pT3 combined with mucinous adenocarcinoma or signet ring cell carcinoma; The incisal margin was positive. 5) Patients and their families can understand the research scheme and are willing to participate in the study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with other tumors within 5 years; 2) Hereditary colorectal cancer; 3) Patients who cannot tolerate peritoneal metastasis therapy; 4) Patients with clinical conditions that do not allow or cannot tolerate laparoscopic exploration; 5) The patient or family members could not understand the conditions and objectives of this study.

Design outcomes

Primary

MeasureTime frame
Proportion of PM detected by laparoscopy at 6 months, 12 months and 18 months after operation;

Secondary

MeasureTime frame
Incidence of PM at 24 months after curative resection of the primary tumour;3-year overall survival;3-year disease-free survival rate;Proportion of peritoneal metastases (R0/R1 resection);Laparoscopic exploration surgery related complications;

Countries

China

Contacts

Public ContactYu Lin

Union Hospital Affiliated to Fujian Medical University

linyu19610505@163.com+86 185 5987 9901

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026