Efficacy and safety of robot-assisted surgery for pancreatic tumors

Phase 1

• Conditions: pancreatic tumors

• Registration Number: JPRN-UMIN000043932
• Lead Sponsor: Kyoto Prefectural University of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Study Completion: 2022-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with highly advanced cancer, such as those with invasion of other organs 2) Patients with giant tumors with a tumor diameter of 8 cm or more 3) Patients with a history of gastrointestinal surgery by laparotomy (excluding appendicectomy) 4) Patients requiring urgent surgery 5) Patients with the following complications i. Gastrointestinal bleeding, obstruction of gastrointestinal transit (including paralysis, intestinal obstruction) ii. symptomatic cardiac disease (including unstable angina, myocardial infarction, heart failure) iii. Respiratory dysfunction such as interstitial pneumonia, pulmonary fibrosis, etc. iv. Poorly controlled diabetes mellitus 6) History of the following i. Myocardial infarction ii. Cerebral infarction iii. Deep vein thrombosis, pulmonary infarction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of all adverse events of grade 3 or higher in the perioperative Clavien-Dindo classification

Secondary Outcome Measures

Name	Time	Method
Operation time, blood loss, incidence of pancreatic fistula, and percentage of surgeries completed with robotic assistance