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Clinical trial to evaluate the safety and efficacy of the intraoperative endoscopic system for assisting laparoscopic hepatobiliary and pancreatic surgery

Clinical trial to evaluate the safety and efficacy of the intraoperative endoscopic system for assisting laparoscopic hepatobiliary and pancreatic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091071
Enrollment
Unknown
Registered
2024-10-20
Start date
2024-10-22
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Surgery of liver, gallbladder and pancreas

Interventions

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old = age = 75 years old, gender is not limited; (2) If the researcher determines that hepatobiliary and pancreatic surgery is required; (3) Able to cooperate and complete follow-up and related examinations; (4) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) women who are pregnant or breastfeeding; (2) Severe coagulation dysfunction with obvious bleeding tendency (platelets < 80 x 109 / L); (3) A history of major abdominal surgery, and adhesion within the abdominal cavity is difficult to isolate and expose lesions; (4) Have serious comorbidities that cannot tolerate surgery or anesthesia; (5) cannot tolerate air stomach; (6) Combination of surgical site or systemic infection, severe inflammatory response; (7) The lesion is adjacent to or directly invades the large blood vessels and affects exposure and separation; (8) The researchers determined that liver cancer patients were not suitable for laparoscopic surgery; Hilar involvement or the disease itself requires extensive hilar lymph node dissection; (10) Emergency surgery; (11) laparoscopic surgery requires a combination of multiple organ removal (except for gallbladder removal); Participating in other clinical trials of investigational drugs or devices that have not been completed; (13) The researchers found that patients were not suitable for this project.

Design outcomes

Primary

MeasureTime frame
Rate of unconverted surgery;

Secondary

MeasureTime frame
Operation time;Volume of bleeding during surgery, blood transfusion rate;Pain Rating;The incidence of device defects;Duration of hospitalization after surgery;

Countries

china

Contacts

Public Contactweng shangeng

The First Affiliated Hospital of Fujian Medical University

wangjia@hrbszr.com+86 137 8887 7012

Outcome results

None listed

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