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Real world study on the efficacy evaluation of ultra minimally invasive organ preservation surgery for early retcal cancer

Real world study on the efficacy evaluation of ultra minimally invasive organ preservation surgery for early retcal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079683
Enrollment
Unknown
Registered
2024-01-09
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

rectal cancer

Interventions

the total lesion resection group:NA
the non-full-layer resection group:NA
surgical operation group:NA

Sponsors

The First Medical Center of Chinese PLA General Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for total lesion resection:(1) Preoperative biopsy pathology indicated that HIN was cancerous or cancerous; Lesion size =2cm. (2) Complete clinical stage diagnosis was performed before surgery, including chest CT plain scan, abdominal pelvic CT plain scan + enhancement, superficial lymph node ultrasound, PET-CT, rectal MRI, endoscopic ultrasound and magnification endoscopy; (3) The clinical stage of colorectal cancer was cTisN0M0, cT1aN0M0 or cT1bN0M0. (4) Age: 18-80 years old; (5) Endoscopic therapy and laparoscopic surgery can be tolerated in general; (6) Patients and family members can understand the research protocol and voluntarily participate in the study, and sign informed consent. The inclusion criteria of the non-full-layer resection group were as follows: (1) Preoperative biopsy pathology indicated HIN with or without cancer; The size of the lesion is not limited. (2) Complete clinical stage diagnosis was performed before surgery, including chest CT plain scan, abdominal pelvic CT plain scan + enhancement, superficial lymph node ultrasound, rectal MRI, PET-CT, endoscopic ultrasound and magnification endoscopy; (3) The clinical stage was cTisN0M0 early intestinal cancer or intestinal HIN; (4) Age :18-80 years old; (5) The general condition can tolerate endoscopic therapy and laparoscopic lymph node resection; (6) Patients and family members can understand the research proposal, voluntarily participate in the study, and sign informed consent. The inclusion criteria of surgical operation group were as follows: (1) Preoperative biopsy pathology indicated HIN cancer or cancer or endoscopic unresectable lesions; The size of the lesion is not limited. (2) Complete clinical stage diagnosis was performed before surgery, including chest CT plain scan, abdominal pelvis CT plain scan + enhancement, rectal MRI, superficial lymph node ultrasound, PET-CT, endoscopic ultrasound and magnification endoscopy; (3) The clinical stage of colorectal cancer was cTisN0M0, cT1aN0M0 or cT1bN0M0; (4) Age :18-80 years old; (5) Laparoscopic and open radical surgery can be tolerated in general; (6) Patients and family members can understand the research protocol and voluntarily participate in the study, and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Previous history of gastrointestinal surgery; (2) Have a history of malignant tumors or other malignant tumors; (3) Combined with gastrointestinal bleeding and other emergencies; (4) Special groups: children, pregnant or lactating women, patients with mental illness; (5) Situations in which the researcher considers it inappropriate to be included; (6)Lymph node sampling or report did not conform to the criteria of this study.

Design outcomes

Primary

MeasureTime frame
Recurrence free survival ;

Secondary

MeasureTime frame
Disease Free Survival;Overall Survival;Curative resection rate;

Countries

China

Contacts

Public ContactLinghu Enqiang

The First Medical Center of Chinese PLA General Hospita

linghuenqiang@vip.sina.com+86 350 123 3558

Outcome results

None listed

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