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Prospective evaluation of the safety and effectiveness of abdominal endoscopic surgery system in hepatobiliary and pancreatic surgery

Prospective evaluation of the safety and effectiveness of abdominal endoscopic surgery system in hepatobiliary and pancreatic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071258
Enrollment
Unknown
Registered
2023-05-09
Start date
2023-06-20
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Hepatobiliary and pancreatic disease

Interventions

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. Patients who have been judged by the researchers to need hepatobiliary pancreatectomy; 3. No other anti-tumor therapy or immunotherapy was performed before surgery; 4. No history of other malignant tumors; 5. Able to cooperate with and complete follow-up and related examinations; 6. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Severe coagulation dysfunction, obvious bleeding tendency (platelets < 100x10^9 /L); 3. History of major abdominal surgery; 4. Accompanied by failure of important organs and inability to tolerate general anesthesia; 5. Multiple organ resection requirements (additional surgical removal of surrounding solid organs); 6. Combined with surgical site or systemic infection, severe inflammatory reaction; 7. Patients who have not completed clinical trials of other investigational drugs or devices; 8. Patients considered unsuitable for this project by the investigator.

Design outcomes

Primary

MeasureTime frame
Successful operation;Urinalysis;

Secondary

MeasureTime frame
Operative time;Rate of negative margins;Number of lymph nodes dissected;Time to first flatus after operation;Time to first feeding after operation;Hospital stay;

Countries

China

Contacts

Public ContactTian Xiaodong

Peking University First Hospital

tianxiaodong@pkufh.com+86 139 1163 6280

Outcome results

None listed

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