Gastric CancerPhase 3NCT06608381
Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10)
A Phase 3 study testing Arm I (Total omentectomy), and Arm II (Partial omentectomy) in people with Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
For advanced gastric cancer, surgical resection is the only curable therapeutic strategy. According to minimally invasive approach is adopted in various field of oncologic surgery, laparoscopic gastrectomy with lymph node dissection is becoming a standard not only for early gastric cancer but also for advanced gastric… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Arm I (Total omentectomy), and Arm II (Partial omentectomy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jun 2024to 30 Dec 2031
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the stomach
- Age between 20 to 85 years old
- ECOG PS 0-1, ASA class I-III
- Endoscopically Borrmann type I, II, III
- Clinical T3 and T4a tumors with or without regional lymph node metastases (cT3N0M0~T4aN3M0)
- Capable of minimal invasive radical subtotal gastrectomy with R0 resection in preoperative examinations
- Patients who signed an written consent form approved by the Institutional Review Board(IRB) after receiving sufficient explanations of the contents of the clinical trial
- Domestic patients who are able to follow up for 3 years after surgery
Who cannot join
- Confirmed distant metastasis in preoperative examinations
- Confirmed metastasis in abdominal cavity or distant organs during surgery
- Confirmed no infiltration of the serosa layer or unable to confirm the tumor location during surgery (sT1-2)
- Confirmed invasion of surrounding organs (sT4b)
- History of previous gastrectomy or greater omentum related surgery
- Patients who underwent preoperative treatment (chemotherapy, radiotherapy, or endoscopic submucosal dissection) for recently diagnosed gastric cancer
Show all 11Show fewer
- Synchronous or metachronous malignancies, which underwent surgery, chemotherapy or radiotherapy within 5 years
- Patients judged to be inappropriate for the study by the physician. (ex. Pregnancy)
- Patients refused to participate after random assignment
- Surgery is not performed until 30 days after consenting to participate
- Patients who has participated in another on-going clinical trial, which is related surgical procedures and survival.
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
GangnamSeverance Hospital
Seoul
Jieun Jung, 82-2-2019-4601, gsirb@yuhs.ac
About this study
Official title: Comparison Between Partial Omentectomy and Total Omentectomy During Minimally Invasive Radical Distal Gastrectomy for Clinical T3 and T4a Gastric Cancer; Multicenter Randomized Clinical Trial (KLASS-10)
For advanced gastric cancer, surgical resection is the only curable therapeutic strategy. According to minimally invasive approach is adopted in various field of oncologic surgery, laparoscopic gastrectomy with lymph node dissection is becoming a standard not only for early gastric cancer but also for advanced gastric cancer.
The greater omentum is an organ is known to play a role in removing bacteria in the abdominal cavity as a primary defense. Complete resection of the greater omentum has been considered essential to ensure the elimination of micrometastasis during surgery for advanced gastric cancer. However, the oncological effect of total omentectomy is still lack of evidence. Especially in minimal invasive gastrectomy, total omentectomy procedure is known to increases the operating time, increase the risk of bleeding, colonic injury, and postoperative complications such as intra-abdominal abscess, ascites, anastomotic leakage, ileus and wound infections. Therefore, in the case of minimal invasive surgery in early gastric cancer, omentectomy is omitted usually or routinely. Partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Advanced energy devices facilitate partial omentectomy during laparoscopic gastrectomy.
Read more
According to the Japanese Gastric Cancer Treatment Guidelines, partial omentectomy (omentum preservation) is feasible for T1 or T2 tumors, and total omentectomy is recommended for clinical T3 or deeper tumors. However, the National Comprehensive Cancer Network(NCCN) guideline suggests total omentectomy and the European Society for Medical Oncology(ESMO) guideline does not mentioned about it.
It is still controversial whether total omentectomy should be performed in advanced gastric cancer. Therefore, we aimed to verify the non-inferiority of partial omentectomy, oncologic safety compared with total omentectomy via multicenter randomized clinical trial.
- Conditions
- Gastric Cancer
- Being tested
- Arm I (Total omentectomy),, Arm II (Partial omentectomy)
- 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 (Total omentectomy),Procedure or surgery
The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups.
Arm II (Partial omentectomy)Procedure or surgery
The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Total omentectomy group | Active comparator | During minimally invasive radical gastrectomy and D2 lymph node dissection, total omentectomy will be performed. Receives: Procedure: Arm I (Total omentectomy), |
| Partial omentectomy group | Experimental | During minimally invasive radical gastrectomy and D2 lymph node dissection, partial omentectomy will be performed. Receives: Procedure: Arm II (Partial omentectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year relapse free survival
Verify the non-inferiority of partial omentectomy(omentum preservation) in 3-year relapse free survival(RFS). Kaplan-Meier and log-rank tests will be used.
Measured: 3 year after surgery
Secondary outcomes (5)
3-year overall survival
To compare surgical outcomes between the partial omentectomy and total omentectomy in patients with advanced gastric cancer, especially clinical T3 and T4a tumors without distant metastasis, who underwent minimal invasive radical gastrectomy and D2 lymph node dissection.
Clinicopathologic features and surgical outcomes will be analyzed using an paired t-test for continuous variables and the Chi-square test or Fisher's exact test for nominal variables. In the survival analysis, the Kaplan-Meier and log-rank tests will be used. Surgical complications will be graded according to the Clavien-Dindo classification.
Measured: 3 year after surgery
Estimated blood loss
To compare surgical outcomes between the partial omentectomy and total omentectomy in patients with advanced gastric cancer, especially clinical T3 and T4a tumors without distant metastasis, who underwent minimal invasive radical gastrectomy and D2 lymph node dissection.
Clinicopathologic features and surgical outcomes will be analyzed using an paired t-test for continuous variables and the Chi-square test or Fisher's exact test for nominal variables. In the survival analysis, the Kaplan-Meier and log-rank tests will be used. Surgical complications will be graded according to the Clavien-Dindo classification.
Measured: during surgery
Operation time
To compare surgical outcomes between the partial omentectomy and total omentectomy in patients with advanced gastric cancer, especially clinical T3 and T4a tumors without distant metastasis, who underwent minimal invasive radical gastrectomy and D2 lymph node dissection.
Clinicopathologic features and surgical outcomes will be analyzed using an paired t-test for continuous variables and the Chi-square test or Fisher's exact test for nominal variables. In the survival analysis, the Kaplan-Meier and log-rank tests will be used. Surgical complications will be graded according to the Clavien-Dindo classification.
Measured: during surgery
Post-operative complications (Early, and delayed complication)
To compare surgical outcomes between the partial omentectomy and total omentectomy in patients with advanced gastric cancer, especially clinical T3 and T4a tumors without distant metastasis, who underwent minimal invasive radical gastrectomy and D2 lymph node dissection.
Clinicopathologic features and surgical outcomes will be analyzed using an paired t-test for continuous variables and the Chi-square test or Fisher's exact test for nominal variables. In the survival analysis, the Kaplan-Meier and log-rank tests will be used. Surgical complications will be graded according to the Clavien-Dindo classification.
Measured: 1 month after surgery & 3 year after surgery ( Evaluate 2 times to analyze early complication, and delayed complication respectively)
Post-operative mortality
To compare surgical outcomes between the partial omentectomy and total omentectomy in patients with advanced gastric cancer, especially clinical T3 and T4a tumors without distant metastasis, who underwent minimal invasive radical gastrectomy and D2 lymph node dissection.
Clinicopathologic features and surgical outcomes will be analyzed using an paired t-test for continuous variables and the Chi-square test or Fisher's exact test for nominal variables. In the survival analysis, the Kaplan-Meier and log-rank tests will be used. Surgical complications will be graded according to the Clavien-Dindo classification.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start26 Jun 2024
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Dec 2031 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random group assignment during operation * Control group : Total omentectomy * Experimental group : Partial omentectomy Other surgical procedures are the same as usual in both groups.
- Masking
- None (open label)
- Enrolment
- 440 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
- NCT06608381
- Sponsor's protocol ID
- 3-2023-0385
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Partial Omentectomy and Total Omentectomy During Minimally Invasive Radical Distal Gastrectomy for Clinical T3 and T4a Gastric Cancer; Multicenter Randomized Clinical Trial (KLASS-10)
- ClinicalTrials.gov ID
- NCT06608381
- Acronym / sponsor ID
- 3-2023-0385
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 23 Sep 2024 (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.
For advanced gastric cancer, surgical resection is the only curable therapeutic strategy. According to minimally invasive approach is adopted in various field of oncologic surgery, laparoscopic gastrectomy with lymph node dissection is becoming a standard not only for early gastric cancer but also for advanced gastric cancer.
The greater omentum is an organ is known to play a role in removing bacteria in the abdominal cavity as a primary defense. Complete resection of the greater omentum has been considered essential to ensure the elimination of micrometastasis during surgery for advanced gastric cancer. However, the oncological effect of total omentectomy is still lack of evidence. Especially in minimal invasive gastrectomy, total omentectomy procedure is known to increases the operating time, increase the risk of bleeding, colonic injury, and postoperative complications such as intra-abdominal abscess, ascites, anastomotic leakage, ileus and wound infections. Therefore, in the case of minimal invasive surgery in early gastric cancer, omentectomy is omitted usually or routinely. Partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Advanced energy devices facilitate partial omentectomy during laparoscopic gastrectomy.
According to the Japanese Gastric Cancer Treatment Guidelines, partial omentectomy (omentum preservation) is feasible for T1 or T2 tumors, and total omentectomy is recommended for clinical T3 or deeper tumors. However, the National Comprehensive Cancer Network(NCCN) guideline suggests total omentectomy and the European Society for Medical Oncology(ESMO) guideline does not mentioned about it.
It is still controversial whether total omentectomy should be performed in advanced gastric cancer. Therefore, we aimed to verify the non-inferiority of partial omentectomy, oncologic safety compared with total omentectomy via multicenter randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random group assignment during operation * Control group : Total omentectomy * Experimental group : Partial omentectomy Other surgical procedures are the same as usual in both groups.
| Arm | Type | Receives |
|---|---|---|
| Total omentectomy group | Active comparator | Procedure: Arm I (Total omentectomy),During minimally invasive radical gastrectomy and D2 lymph node dissection, total omentectomy will be performed. |
| Partial omentectomy group | Experimental | Procedure: Arm II (Partial omentectomy)During minimally invasive radical gastrectomy and D2 lymph node dissection, partial omentectomy will be performed. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven adenocarcinoma of the stomach
- Age between 20 to 85 years old
- ECOG PS 0-1, ASA class I-III
- Endoscopically Borrmann type I, II, III
- Clinical T3 and T4a tumors with or without regional lymph node metastases (cT3N0M0~T4aN3M0)
Key exclusion criteria (11 listed)
- Confirmed distant metastasis in preoperative examinations
- Confirmed metastasis in abdominal cavity or distant organs during surgery
- Confirmed no infiltration of the serosa layer or unable to confirm the tumor location during surgery (sT1-2)
- Confirmed invasion of surrounding organs (sT4b)
- History of previous gastrectomy or greater omentum related surgery
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 (Total omentectomy),The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups. | Procedure or surgery | Total omentectomy group |
| Arm II (Partial omentectomy)The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups. | Procedure or surgery | Partial omentectomy group |
Primary outcome
3-year relapse free survival
Time frame: 3 year after surgery
Verify the non-inferiority of partial omentectomy(omentum preservation) in 3-year relapse free survival(RFS). Kaplan-Meier and log-rank tests will be used.
5 secondary outcomes
3-year overall survival
Time frame: 3 year after surgery
Estimated blood loss
Time frame: during surgery
Operation time
Time frame: during surgery
Post-operative complications (Early, and delayed complication)
Time frame: 1 month after surgery & 3 year after surgery ( Evaluate 2 times to analyze early complication, and delayed complication respectively)
Post-operative mortality
Time frame: 3 months after surgery
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 23 Sep 2024.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing Arm I (Total omentectomy), and Arm II (Partial omentectomy) in people with 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 8 inclusion and 11 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 23 Sep 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year relapse free survival (time frame: 3 year after 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 23 Sep 2024.