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A new clinical technique to evaluate the safety and efficacy of endoscopic laparoscopy system (NT-ES1000)

A new clinical technique to evaluate the safety and efficacy of endoscopic laparoscopy system (NT-ES1000)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079081
Enrollment
Unknown
Registered
2023-12-25
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Hepatobiliary and pancreatic surgical diseases feasible for laparoscopic surgery

Interventions

Experimental group:Robotically-assisted laparoscopic surgery system (NT-ES1000) was used to perform minimally invasive abdominal surgery in hepatobiliary and pancreatic surgery

Sponsors

The Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-75; (2) It meets the relevant indications of laparoscopic robotic pneumoperitoneo-free cholecystectomy, cholecystectomy + choledochotomy T-tube drainage, liver lesion resection, pancreas lesion resection and splenectomy; (3) There are diagnostic certificates and/or pathological reports of imaging examinations of relevant target lesion sites (1 month before the information is acceptable); (4) Be able to understand and comply with the clinical study protocol, voluntarily participate in the clinical study, and the subject or his legal representative sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) In patients with severe bleeding tendency, activated partial thromboplastin time >1.5 times the upper limit of normal value; (2) Abdominal infection, peritonitis, diaphragmatic hernia, serious systemic infection; (3) pregnant, lactating women or women planning to give birth; (4) severe abnormal liver and kidney function; (5) Patients with serious cardiovascular or circulatory diseases or suspected or confirmed allergies to surgical anesthetics; (6) Participate in other clinical studies within 1 month before signing the informed consent; (7) Patients who have had abdominal surgery within 1 year before signing the informed consent; (8) Patients diagnosed with ascites or suspected ascites by imaging examination; (9) Patients with a history of gastrointestinal surgery or partial hepatectomy; (10) Epilepsy and other serious neurological diseases; (11) Depression, mania and other serious mental illness; (12) Patients with a history of cerebral infarction or cerebral hemorrhage within 1 year before signing the informed consent; (13) Tumor patients who had received neoadjuvant therapy before signing the informed consent; (14) Other reasons that the researcher considers inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
surgical unconversion rate;

Secondary

MeasureTime frame
Instrument-assisted operation time;Intraoperative blood loss;Blood transfusion rate;Instrument defect rate;Incidence of postoperative complications;Incidence of adverse events and serious adverse events;Reoperation rate;30-day readmission rate;Instrument performance evaluation;mortality rate;Subject pain score;Length of stay;

Countries

China

Contacts

Public ContactShengYan

The Second Affiliated Hospital, School of Medicine, Zhejiang University

shengyan@zju.edu.cn+86 139 5716 1680

Outcome results

None listed

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