Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical GastrectomyNCT07100431
Comparison of Safety and Clinical Effects of Straight and Articulated Instruments (ArtiSential) in Laparoscopic Gastrectomy for Gastric Cancer Patients, a Prospective Randomized Study
A study testing Articulating (experimental group) in people with Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
In patients with gastric cancer, gastrectomy can be performed via laparoscopic/robotic or open surgery. It is crucial to completely remove the tumor along with an adequate extent of lymph node dissection. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy
- What is being tested?
- Articulating (experimental group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 diagnosed with gastric adenocarcinoma pathologically before surgery
- Patients scheduled for laparoscopic radical gastrectomy
- Patients aged more than 20
- Patients with an ECOG 0 or 1
Who cannot join
- Patients with a history of gastrectomy
- Patients with a history of pancreatitis or pancreatic surgery
- Patients with a history of abdominal surgery who are expected to have severe intra-abdominal adhesions
- Patients scheduled for total gastrectomy with D2 lymph node dissection
Trial locations and contacts
1 site in 1 country.
About this study
In patients with gastric cancer, gastrectomy can be performed via laparoscopic/robotic or open surgery. It is crucial to completely remove the tumor along with an adequate extent of lymph node dissection. The number of lymph nodes retrieved during gastrectomy is considered an important factor associated with the quality of the surgery and can serve as an indicator of the completeness of the procedure.
In particular, during the dissection of lymph node stations 8, 9, 11p and 12a - which are located near the superior aspect of the pancreas - pressure is often applied to the pancreas to secure an adequate surgical view. Recent studies have suggested that this may be associated with postoperative pancreatic complications.
It is believed that the use of articulating instruments during laparoscopic gastrectomy may enable a safer dissection of lymph nodes located above the pancreas. However, to date, there have been lack of studies comparing the safety and efficacy of articulating versus straight instruments in laparoscopic gastrectomy. Therefore, this study aims to analyze the compare these two approaches.
- Being tested
- Articulating (experimental group), Control (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articulating (experimental group)Procedure or surgery
- Surgical procedure On the day of surgery, random allocation to either the experimental or the control group will be perfored just before the start of the procedure. All of the surgery will be conducted laparoscopically. The control group will undergo surgery using a conventional straight laparoscopic instrument, while the experimental group will use an articulating instrument. The surgical procedure will be the same for both groups. The total time of surgery and the time spent on the supra-pancreatic lymph node dissection will be recorded during the procedure. The estimated blood loss during surgery will be also measured.
Control (control group)Procedure or surgery
- Postoperative follow-up Patients participating in this study will have the same postoperative care as those not participating in this study. To compare the degree of pancreatic injury, amylase and lipase levels will be measured in the serum and the peritoneal fluid frome the drainage on postoperative days 1 and 3.
Postoperative complications will be classified and recorded according to the Clavien-Dindo classification for all complications occurring within 30 days after surgery. The dissected lymph nodes will be categorized by region, and the number of dissected lymph nodes will also be confirmed.
| Study group | Role | What they receive |
|---|---|---|
| Articulating group | Experimental | During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with an articulating laparoscopic instrument (ArtiSential®, LIVSMED, Maryland jaw) in their left hand. Receives: Procedure: Articulating (experimental group); Procedure: Control (control group) |
| Control group | No intervention | During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with a conventional straight laparoscopic instrument in their left hand. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction in operative time achieved by using an articulating instrument for dissection of suprapancreatic lymph nodes during laparoscopic gastrectomy
To confirm that the use of articulating instruments in radical gastrectomy can lead to more efficient and safer surgery compared to conventional straight instruments.
Measured: During surgery, the total operation time, and the supra-pancreatic lymph node dissection time will be calculated respectively. The supra-pancreatic lymph node dissection time will be measured from the point of right gastric artery ligation to just before
Secondary outcomes (3)
The degree of pancreas injury after surgery
To confirm that the use of articulating instruments in radical gastrectomy can lead to more efficient and safer surgery compared to conventional straight instruments.
Measured: Amylase levels will be measured in serum and peritoneal fluid on postoperative day 1 and 3.
Estimated blood loss
To confirm that the use of articulating instruments in radical gastrectomy can lead to more efficient and safer surgery compared to conventional straight instruments.
Measured: Estimated blood loss will be calculated during surgery.
The number of retrieved lymph nodes
To confirm that the use of articulating instruments in radical gastrectomy can lead to more efficient and safer surgery compared to conventional straight instruments.
Measured: The number of retrieved lymph nodes were counted after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start22 Jun 2022
- Primary completion15 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical GastrectomyStudies 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
- During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with an instrument in their left hand to secure a clear surgical view. In the Control group, a conventional straight laparoscopic instrument was used for this purpose, while in the Articulating group, an articulating laparoscopic instrument (ArtiSential®, LIVSMED, Maryland jaw) was used.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
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
- NCT07100431
- Sponsor's protocol ID
- 3-2022-0165
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 3 Aug 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Clinical Effects of Straight and Articulated Instruments (ArtiSential) in Laparoscopic Gastrectomy for Gastric Cancer Patients, a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07100431
- Acronym / sponsor ID
- 3-2022-0165
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Aug 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.
In patients with gastric cancer, gastrectomy can be performed via laparoscopic/robotic or open surgery. It is crucial to completely remove the tumor along with an adequate extent of lymph node dissection. The number of lymph nodes retrieved during gastrectomy is considered an important factor associated with the quality of the surgery and can serve as an indicator of the completeness of the procedure.
In particular, during the dissection of lymph node stations 8, 9, 11p and 12a - which are located near the superior aspect of the pancreas - pressure is often applied to the pancreas to secure an adequate surgical view. Recent studies have suggested that this may be associated with postoperative pancreatic complications.
It is believed that the use of articulating instruments during laparoscopic gastrectomy may enable a safer dissection of lymph nodes located above the pancreas. However, to date, there have been lack of studies comparing the safety and efficacy of articulating versus straight instruments in laparoscopic gastrectomy. Therefore, this study aims to analyze the compare these two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with an instrument in their left hand to secure a clear surgical view. In the Control group, a conventional straight laparoscopic instrument was used for this purpose, while in the Articulating group, an articulating laparoscopic instrument (ArtiSential®, LIVSMED, Maryland jaw) was used.
| Arm | Type | Receives |
|---|---|---|
| Articulating group | Experimental | Procedure: Articulating (experimental group), Procedure: Control (control group)During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with an articulating laparoscopic instrument (ArtiSential®, LIVSMED, Maryland jaw) in their left hand. |
| Control group | No intervention | –During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with a conventional straight laparoscopic instrument in their left hand. |
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 diagnosed with gastric adenocarcinoma pathologically before surgery
- Patients scheduled for laparoscopic radical gastrectomy
- Patients aged more than 20
- Patients with an ECOG 0 or 1
Key exclusion criteria (4 listed)
- Patients with a history of gastrectomy
- Patients with a history of pancreatitis or pancreatic surgery
- Patients with a history of abdominal surgery who are expected to have severe intra-abdominal adhesions
- Patients scheduled for total gastrectomy with D2 lymph node dissection
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 |
|---|---|---|
| Articulating (experimental group)1. Surgical procedure On the day of surgery, random allocation to either the experimental or the control group will be perfored just before the start of the procedure. All of the surgery will be conducted laparoscopically. The control group will undergo surgery using a conventional straight laparoscopic instrument, while the experimental group will use an articulating instrument. The surgical procedure will be the same for both groups. The total time of surgery and the time spent on the supra-pancreatic lymph node dissection will be recorded during the procedure. The estimated blood loss during surgery will be also measured. | Procedure or surgery | Articulating group |
| Control (control group)2. Postoperative follow-up Patients participating in this study will have the same postoperative care as those not participating in this study. To compare the degree of pancreatic injury, amylase and lipase levels will be measured in the serum and the peritoneal fluid frome the drainage on postoperative days 1 and 3. Postoperative complications will be classified and recorded according to the Clavien-Dindo classification for all complications occurring within 30 days after surgery. The dissected lymph nodes will be categorized by region, and the number of dissected lymph nodes will also be confirmed. | Procedure or surgery | Articulating group |
Primary outcome
The reduction in operative time achieved by using an articulating instrument for dissection of suprapancreatic lymph nodes during laparoscopic gastrectomy
Time frame: During surgery, the total operation time, and the supra-pancreatic lymph node dissection time will be calculated respectively. The supra-pancreatic lymph node dissection time will be measured from the point of right gastric artery ligation to just before
To confirm that the use of articulating instruments in radical gastrectomy can lead to more efficient and safer surgery compared to conventional straight instruments.
3 secondary outcomes
The degree of pancreas injury after surgery
Time frame: Amylase levels will be measured in serum and peritoneal fluid on postoperative day 1 and 3.
Estimated blood loss
Time frame: Estimated blood loss will be calculated during surgery.
The number of retrieved lymph nodes
Time frame: The number of retrieved lymph nodes were counted after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articulating (experimental group) in people with Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy, 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 4 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: finished, as of the sponsor's last update on 3 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction in operative time achieved by using an articulating instrument for dissection of suprapancreatic lymph nodes during laparoscopic gastrectomy (time frame: During surgery, the total operation time, and the supra-pancreatic lymph node dissection time will be calculated respectively. The supra-pancreatic lymph node dissection time will be measured from the point of right gastric artery ligation to just before). 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 3 Aug 2025.