Gastric CancerNCT06841484
Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy
A study of Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
- Patients who have undergone a complete (R0) resection.
- Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
- Patients undergoing robotic radical distal gastrectomy.
Who cannot join
- Patients under 19 years of age.
- Patients who have received preoperative chemotherapy or radiotherapy.
- Patients diagnosed with stage IV gastric cancer due to distant metastasis.
- Patients diagnosed with malignancies other than gastric cancer.
- Patients scheduled to undergo total gastrectomy.
- Patients requiring total omentectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeveranceHospital
Seoul
InGyu Kwon
About this study
Official title: Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study
This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.
- Conditions
- Gastric Cancer
- Being tested
- Arm I (Assistant-Controlled Laparoscopic Instrumentation), Arm II (Assistant-Controlled Laparoscopic Instrumentation)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Assistant-Controlled Laparoscopic Instrumentation)Procedure or surgery
In this group, robotic distal gastrectomy is performed with assistant-controlled laparoscopic instrumentation. The assistant conducts vascular clipping using articulating Hemolock clip appliers (Livsmed) or Challenger® clip appliers (B.Braun). For gastrointestinal anastomosis, the assistant operates an Echelon stapling system (Johnson \& Johnson) via the assistant port. The surgeon controls the robotic console for all other surgical steps. This method utilizes a hybrid approach, combining robotic precision with laparoscopic efficiency.
Arm II (Assistant-Controlled Laparoscopic Instrumentation)Procedure or surgery
In this group, all surgical steps, including vascular clipping and anastomosis, are performed using the robotic system. The surgeon utilizes the Da Vinci Xi system and switches robotic instruments as needed. Vascular clipping is performed with robotic Hemolock or Hemoclip appliers, and anastomosis is conducted using the SureForm robotic stapler. This fully robotic technique eliminates laparoscopic assistance and utilizes only robotic arms for the entire procedure.
Both groups follow the same postoperative care protocols, including standardized pain management and recovery assessments.
| Study group | Role | What they receive |
|---|---|---|
| Assistant-Controlled Group | Experimental | The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system. Receives: Procedure: Arm I (Assistant-Controlled Laparoscopic Instrumentation) |
| Full Robotic Group | Active comparator | The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler. Receives: Procedure: Arm II (Assistant-Controlled Laparoscopic Instrumentation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average operative time (in minutes).
The primary outcome is the average operative time (in minutes) from skin incision to skin closure. This measurement will compare surgical efficiency between the assistant-controlled laparoscopic instrumentation group and the full robotic instrumentation group.
Measured: At the end of the surgery
Secondary outcomes (5)
Total cost of consumable surgical materials.
The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records.
Measured: At the end of the surgery (up to 12 hours)
Quality of Recovery (QoR-15) scores at 72 hours postoperatively.
The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records.
Measured: 72 hours postoperatively
Time to first flatus and bowel movement.
The time taken for the patient to pass gas and have a bowel movement will be recorded to assess postoperative gastrointestinal recovery.
Measured: Up to 1 month after surgery
Postoperative laboratory markers (e.g., CRP, WBC).
Inflammatory markers, including C-reactive protein (CRP) and white blood cell (WBC) counts, will be measured from blood samples to evaluate the patient's inflammatory response.
Measured: Up to 5 days after surgery
Incidence of postoperative complications.
The incidence of postoperative complications, including infections, bleeding, anastomotic leakage, and other surgical site issues, will be recorded and classified according to the Clavien-Dindo classification.
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blind Randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Kwon, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841484
- Sponsor's protocol ID
- 3-2024-0426
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT06841484
- Acronym / sponsor ID
- 3-2024-0426
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single Blind Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Assistant-Controlled Group | Experimental | Procedure: Arm I (Assistant-Controlled Laparoscopic Instrumentation)The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system. |
| Full Robotic Group | Active comparator | Procedure: Arm II (Assistant-Controlled Laparoscopic Instrumentation)The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
- Patients who have undergone a complete (R0) resection.
- Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
- Patients undergoing robotic radical distal gastrectomy.
Key exclusion criteria (6 listed)
- Patients under 19 years of age.
- Patients who have received preoperative chemotherapy or radiotherapy.
- Patients diagnosed with stage IV gastric cancer due to distant metastasis.
- Patients diagnosed with malignancies other than gastric cancer.
- Patients scheduled to undergo total gastrectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm I (Assistant-Controlled Laparoscopic Instrumentation)In this group, robotic distal gastrectomy is performed with assistant-controlled laparoscopic instrumentation. The assistant conducts vascular clipping using articulating Hemolock clip appliers (Livsmed) or Challenger® clip appliers (B.Braun). For gastrointestinal anastomosis, the assistant operates an Echelon stapling system (Johnson \& Johnson) via the assistant port. The surgeon controls the robotic console for all other surgical steps. This method utilizes a hybrid approach, combining robotic precision with laparoscopic efficiency. | Procedure or surgery | Assistant-Controlled Group |
| Arm II (Assistant-Controlled Laparoscopic Instrumentation)In this group, all surgical steps, including vascular clipping and anastomosis, are performed using the robotic system. The surgeon utilizes the Da Vinci Xi system and switches robotic instruments as needed. Vascular clipping is performed with robotic Hemolock or Hemoclip appliers, and anastomosis is conducted using the SureForm robotic stapler. This fully robotic technique eliminates laparoscopic assistance and utilizes only robotic arms for the entire procedure. Both groups follow the same postoperative care protocols, including standardized pain management and recovery assessments. | Procedure or surgery | Full Robotic Group |
Primary outcome
Average operative time (in minutes).
Time frame: At the end of the surgery
The primary outcome is the average operative time (in minutes) from skin incision to skin closure. This measurement will compare surgical efficiency between the assistant-controlled laparoscopic instrumentation group and the full robotic instrumentation group.
5 secondary outcomes
Total cost of consumable surgical materials.
Time frame: At the end of the surgery (up to 12 hours)
Quality of Recovery (QoR-15) scores at 72 hours postoperatively.
Time frame: 72 hours postoperatively
Time to first flatus and bowel movement.
Time frame: Up to 1 month after surgery
Postoperative laboratory markers (e.g., CRP, WBC).
Time frame: Up to 5 days after surgery
Incidence of postoperative complications.
Time frame: Within 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In Gyu Kwon (82-2-2019-4601, gsirb@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average operative time (in minutes). (time frame: At the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.