Health TrialsbyHealthPanel

Robotic Gastrectomy With 5th Arm

ConditionStomach Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong

About this trial

This is a multicenter single arm clinical pilot study to investigate the safety and feasibility of a novel multiport Sentire Robotic Surgical System with Patient Side Single Arm (5th arm) in patients with gastric cancer undergoing robotic radical gastrectomy. 10 adult patients with newly diagnosed cancer of the stomach deemed operable would be recruited from Prince of Wales Hospital, Hong Kong and Fujita Health University Hospital, Nagoya, Japan.

The primary aim of this study is to determine the feasibility of robotic surgical procedures performed using the Cornerstone Robotics Sentire Surgical System C1000 Ultra, as measured by the technical success rate of surgery, and to evaluate the safety of the procedures as measured by the incidence of perioperative complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75

Body mass index <35 kg/m2

Newly diagnosed tumors of the stomach / gastro-esophageal junction, scheduled to undergo elective gastrectomy (Proximal gastrectomy, distal gastrectomy, total gastrectomy)

Willingness to participate as demonstrated by giving informed consent

Disqualifiers

Previous abdominal surgery precluding performance of MIS gastrectomy

Contraindication to general anesthesia

Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention

Untreated active infection

Trial design

Design model

Single group

Treatments tested in this trial

  • Robotic gastrectomy performed with Cornerstone Robotics Sentire Surgical System C1000 Ultra (With Patient Side Single Arm)

    Device

    Under general anesthesia, the patient will be placed in a supine position in reverse Trendelenburg tilt. A 25-mm transumbilical incision will be made to allow placement of a GelPOINT Mini Advanced Access Platform (Applied Medical Ltd) and introduction of capno-peritoneum. Through the GelPOINT seal cap, robotic 8-10mm camera port and an accessory 12mm port will be introduced. Laparoscopic insertion of the other four ports of 8 mm for placement of robotic arms will be performed. After confirming port positions, docking of the Sentire Surgical System C1000 Ultra would be performed. The main Patient Side Robot (PSR) will be introduced from the patient's left shoulder side, while the Patient Side Single Arm will be introduced from the patient's right side. Distal gastrectomy, total gastrectomy and proximal gastrectomy will be performed according to the Japanese Treatment Guidelines of Gastric Cancer.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: 5th arm groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical success

Successful completion of the intended surgical procedure using the Sentire Surgical System C1000 Ultra, without conversion the treatment plan to conventional minimally invasive laparoscopic surgery or to open surgery.

Time frame
1 day

Secondary outcomes

1

Intra-operative complication

The rate of intra-operative complications

Time frame
1 day
2

Post-procedural complication

The rate of post-procedural complication, as graded by Clavien Dindo Classification

Time frame
30 days or in-hospital
3

Operative time

Procedure time of the robotic gastrectomy

Time frame
1 day
4

Intraoperative blood loss

The volume of blood loss estimated during procedure (ml)

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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