Clinical Trials Logo

Clinical Trial Summary

By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy and scheduled for robotic total gastrectomy, RUS™ will operate normally to check whether patient-specific surgical navigation is available before or during surgery. In particular, when using the patient-specific surgery simulation system provided by RUS™, the CT information provides a patient-specific 3D environment well, so it will be checked regarding whether the surgeon can use it before or during surgery without any particular problems. Using RUS™ software, navigation information is used before or during surgery, and among these, parts that can be quantitatively compared with actual measurements will be evaluated as a secondary research goal. After the surgery, the investigators plan to check the amount of bleeding, duration of hospitalization, and the rate of complications by performing robot gastrointestinal resection using the navigation system to ensure that there are no problems with patient safety.

Clinical Trial Description

- Obtain consent from a patient who is diagnosed with gastric cancer and is scheduled for robotic surgery. - Take an abdominal CT before gastric cancer surgery according to the prescribed protocol. - Upload patient information and CT information before surgery to RUS™, an endoscopic treatment image planning software, to build a 3D modeling navigation system for a patient-customized surgical environment. (Measure the time (in days) from the time the CT is uploaded to the time when the RUS™ software can be operated.) - Before surgery, use the RUS™ navigation system to check the patient's relief and anatomical structure, mark the planned trocar insertion site, and obtain distance information from the umbilical trocar. ⑤ After general anesthesia on the day of surgery, mark the Landmark 25 area on the abdominal wall using a surgical marking pen. In addition, the abdominal wall surface scan is performed using a laser 3D scanner. ⑥ After the undulations are formed, the deformed abdominal wall surface is scanned with a laser 3D scanner. ⑦ Evaluate the degree of agreement between the patient's actual relief state measured in steps ⑤ and ⑥ and the patient's relief model predicted through the relief prediction model in RUS™. ⑧ When the trocar is inserted through an anatomical landmark after the actual patient's relief, compare the position information of the trocar with the trocar position information of the RUS™ measured in advance in step ④ to check its accuracy. ⑨ Check whether the blood vessels that must be checked during the total gastrectomy procedure (left omentary artery, left umbilical vein, superior omentum, superior vena cava, left gastric artery, superior artery, and left hepatic branching left hepatic artery) are presented in the RUS™ blood vessel segmentation model. ⑩ Among the vessels mentioned in step ⑨, for the vessels suggested by RUS™ for vessels (left gastric artery, superior artery, left gastric vein, and gastric colonic vein), check the anatomical positional relationship and measure branch points during actual surgery. Check the accuracy of matching with the anatomical location information and branching distance of the segmentation model. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05039333
Study type Observational
Source Hutom Corp
Contact Yu Min Kim, Professor
Phone +82-2-2228-2100
Email [email protected]
Status Not yet recruiting
Start date September 1, 2021
Completion date June 23, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT03746704 - Study of ImmunoPet Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504 in Participants With Advanced PD-L1 Positive Malignancies Phase 1
Not yet recruiting NCT04105062 - LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery Phase 1/Phase 2
Recruiting NCT04082364 - Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Active, not recruiting NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04354662 - Toripalimab Combined With FLOT Neoadjuvant Chemotherapy in Patients With Resectable Gastric Cancer Phase 2
Recruiting NCT04062656 - Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG Phase 2
Recruiting NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Not yet recruiting NCT03273920 - Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer N/A
Active, not recruiting NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04553692 - Phase I Study of IGM-8444 as a Single Agent and in Combination in Subjects With Relapsed and/or Refractory Solid Cancers Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Not yet recruiting NCT04535414 - Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers Phase 2
Active, not recruiting NCT04842916 - InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer