Gastric CancerKLASS-04NCT02595086
Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy
A study testing Laparoscopic PPG and Laparoscopic DG in people with Gastric Cancer, run by Seoul National University Hospital at 5 sites in South Korea.
Trial summary
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic PPG and Laparoscopic DG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jul 2015to Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are included in the trial if they meet all of the following criteria:
- histologically proven primary gastric adenocarcinoma
- aged 20-80 years old
- performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score
- clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
- location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)
- written signed informed consent
Who cannot join
- Patients are excluded if they meet any of the following criteria:
- pyloric deformity because peptic ulcer disease
- previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
- synchronous lesion of early gastric cancer or adenoma in antrum
- prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
- patients who need combined resection (eg. cholecystectomy)
- vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
- participated in another clinical trial within the last six months or currently involved patients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Kyungpook National University Hospital
Daegu, Jung-gu, 700-721
National Cacner Center
Goyang-si
Department of Surgery, Seoul National University BUNDANG Hospital
Seongnam
Seoul National University Hospital
Seoul
Yonsei University Severance Hospital
Seoul
About this study
Official title: Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer
Read the detailed description
Participating Surgeons
Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.
Patients Registration
It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center.
Each group 128 patients, total 256 subjects will be enrolled.
Randomization
The registration randomization should be done with 1:1 ratio for each researcher.
Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.
Procedure
Operations are performed according to the allocated group.
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic PPG, Laparoscopic DG
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic PPGProcedure or surgery
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
Laparoscopic DGProcedure or surgery
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic PPG | Experimental | Laparoscopy assisted pylorus-preserving gastrectomy(LPPG) with D1+ lymphadenectomy is performed (exclude lymph node station No. 5) in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Extra-corporeal gastro-gastrostomy should be performed Receives: Procedure: Laparoscopic PPG |
| Laparoscopic DG | Active comparator | Laparoscopic distal gastrectomy(LDG) with D1+ lymphadenectomy in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Anastomosis method (extra-corporeal or intra-) and reconstruction type (Billroth I (gastroduodenostomy), Billroth II, or Roux-en Y gastrojejunostomy) are optional according to the surgeon's preference Receives: Procedure: Laparoscopic DG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
Measured: 1 years postoperatively
Secondary outcomes (12)
Relapse-free survival
Measured: 3 years postoperatively
Overall survival
Measured: 3 years postoperatively
Operative morbidity
Measured: 30 days for early morbidity
Operative mortality
Measured: mortality for 90 days
Body weight change
Measured: check at every visit up to 3 years postoperatively
Fat volume change on abdominal CT scan
Measured: check at every 1 year up to 3 years postoperatively
Change of Hemoglobin
Measured: check at every visit up to 3 years postoperatively
Change of Protein
Measured: check at every visit up to 3 years postoperatively
Change of Albumin
Measured: check at every visit up to 3 years postoperatively
QOL measurement (EORTC C30/STO22) (composite)
Measured: 6 month, 1 year, 2 year, 3 year postoperatively
Incidence of gallbladder stone
Measured: check at every 6 months up to 3 years postoperatively
Gross and microscopic changes measured by gastroscopy (composite)
Measured: 1 year, 2 year, 3 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyuk-Joon Lee, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595086
- Sponsor's protocol ID
- KLASS-04
- Acronym
- KLASS-04
- Status last verified
- Oct 2020
- First submitted
- 2 Jul 2015
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park DJ, Kim YW, Yang HK, Ryu KW, Han SU, Kim HH, Hyung WJ, Park JH, Suh YS, Kwon OK, Yoon HM, Kim W, Park YK, Kong SH, Ahn SH, Lee HJ. Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial). Br J Surg. 2021 Sep 27;108(9):1043-1049. doi: 10.1093/bjs/znab295.
PubMed 34487147
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
- ClinicalTrials.gov ID
- NCT02595086
- Acronym / sponsor ID
- KLASS-04 / KLASS-04
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- 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.
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer
Detailed description
Participating Surgeons
Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.
Patients Registration
It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center.
Each group 128 patients, total 256 subjects will be enrolled.
Randomization
The registration randomization should be done with 1:1 ratio for each researcher.
Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.
Procedure
Operations are performed according to the allocated group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic PPG | Experimental | Procedure: Laparoscopic PPGLaparoscopy assisted pylorus-preserving gastrectomy(LPPG) with D1+ lymphadenectomy is performed (exclude lymph node station No. 5) in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Extra-corporeal gastro-gastrostomy should be performed |
| Laparoscopic DG | Active comparator | Procedure: Laparoscopic DGLaparoscopic distal gastrectomy(LDG) with D1+ lymphadenectomy in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Anastomosis method (extra-corporeal or intra-) and reconstruction type (Billroth I (gastroduodenostomy), Billroth II, or Roux-en Y gastrojejunostomy) are optional according to the surgeon's preference |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologically proven primary gastric adenocarcinoma
- aged 20-80 years old
- performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score
- clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
Key exclusion criteria (8 listed)
- pyloric deformity because peptic ulcer disease
- previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
- synchronous lesion of early gastric cancer or adenoma in antrum
- prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
- patients who need combined resection (eg. cholecystectomy)
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 |
|---|---|---|
| Laparoscopic PPGLaparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification. | Procedure or surgery | Laparoscopic PPG |
| Laparoscopic DGLaparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification. | Procedure or surgery | Laparoscopic DG |
Primary outcome
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
Time frame: 1 years postoperatively
12 secondary outcomes
Relapse-free survival
Time frame: 3 years postoperatively
Overall survival
Time frame: 3 years postoperatively
Operative morbidity
Time frame: 30 days for early morbidity
Operative mortality
Time frame: mortality for 90 days
Body weight change
Time frame: check at every visit up to 3 years postoperatively
Fat volume change on abdominal CT scan
Time frame: check at every 1 year up to 3 years postoperatively
Change of Hemoglobin
Time frame: check at every visit up to 3 years postoperatively
Change of Protein
Time frame: check at every visit up to 3 years postoperatively
Change of Albumin
Time frame: check at every visit up to 3 years postoperatively
QOL measurement (EORTC C30/STO22) (composite)
Time frame: 6 month, 1 year, 2 year, 3 year postoperatively
Incidence of gallbladder stone
Time frame: check at every 6 months up to 3 years postoperatively
Gross and microscopic changes measured by gastroscopy (composite)
Time frame: 1 year, 2 year, 3 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 34487147Park DJ, Kim YW, Yang HK, Ryu KW, Han SU, Kim HH, Hyung WJ, Park JH, Suh YS, Kwon OK, Yoon HM, Kim W, Park YK, Kong SH, Ahn SH, Lee HJ. Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial). Br J Surg. 2021 Sep 27;108(9):1043-1049. doi: 10.1093/bjs/znab295.
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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. This study is not recruiting at the moment.
Hyuk-Joon Lee, M.D., Ph.D. principal investigator
Seoul National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic PPG and Laparoscopic DG in people with Gastric Cancer, run by Seoul National University Hospital at 5 sites 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 8 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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Incidence of Dumping syndrome, assessed by Sigstad score (≥7) (time frame: 1 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595086, which also lists 1 linked publication.
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 Oct 2020.