Early Gastric CancerNCT01938326
Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)
A study testing Approach Method in people with Early Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
1. Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC) 2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC) Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Approach Method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 30 Apr 2020
- 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
- clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds)
- 20< Age < 80
Who cannot join
- history of other malignancy
- received preoperative chemotherapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Official title: Postoperative Pain and Quality of Life After Single-incision Distal Gastrectomy Versus Totally Laparoscopic Distal Gastrectomy for Early Gastric Cancer - a Randomized Controlled Trial
- Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC)
- Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)
Read the detailed description
There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery.
Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published.
However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications.
This study is planned as a phase II study.
There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.
- Conditions
- Early Gastric Cancer
- Being tested
- Approach Method
- Keywords
- Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach MethodProcedure or surgery
SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery)
| Study group | Role | What they receive |
|---|---|---|
| Multi-port laparoscopic distal gastrectomy | Active comparator | Laparoscopic distal gastrectomy using the conventional 5-port access Receives: Procedure: Approach Method |
| Single incision distal gastrectomy | Active comparator | Pure single incision distal gastrectomy using one transumbilical incision Receives: Procedure: Approach Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score using VAS at postoperative day#1
Maximum postoperative pain using the visual analogue scale
Measured: Postoperative day 1
Secondary outcomes (8)
Operation time
Time spent during operation
Measured: Time during operation
Estimated blood loss
Amount of blood loss during operation
Measured: During operation
Early postoperative complication
Postoperative complications within 30 days from the operation
Measured: within 30 days from the operation
Hospital stay
Days until discharge
Measured: Days until discharge
Time to first flatus
Days until first flatus
Measured: Days until first flatus
Time to first soft fluid diet
Days until first soft fluid diet
Measured: Days until first soft fluid diet
Maximum pain scores using VAS
Maximum pain scores using the visual analogue scale
Measured: From postoperative day 0 to 5
EORTC-C30 and STO22
Quality of life questionnaires
Measured: Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 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 posted10 Sep 2013 (estimated)
- Study start1 Sep 2017
- Primary completion27 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Hoon Ahn, Seoul National University Bundang Hospital
- Investigators
- Sang-Hoon Ahn, M.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938326
- Sponsor's protocol ID
- SNUBH-SIDG-GS-PII
- Status last verified
- Sep 2022
- First submitted
- 15 Jul 2012
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Quality of Life After Single-incision Distal Gastrectomy Versus Totally Laparoscopic Distal Gastrectomy for Early Gastric Cancer - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01938326
- Acronym / sponsor ID
- SNUBH-SIDG-GS-PII
- Conditions
- Early Gastric Cancer
- Keywords
- Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 10 Sep 2013 (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.
- Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC)
- Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)
Detailed description
There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery.
Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published.
However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications.
This study is planned as a phase II study.
There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-port laparoscopic distal gastrectomy | Active comparator | Procedure: Approach MethodLaparoscopic distal gastrectomy using the conventional 5-port access |
| Single incision distal gastrectomy | Active comparator | Procedure: Approach MethodPure single incision distal gastrectomy using one transumbilical incision |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds)
- 20< Age < 80
Key exclusion criteria (2 listed)
- history of other malignancy
- received preoperative chemotherapy
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 |
|---|---|---|
| Approach MethodSIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery) | Procedure or surgery | Multi-port laparoscopic distal gastrectomy, Single incision distal gastrectomy |
Primary outcome
Maximum pain score using VAS at postoperative day#1
Time frame: Postoperative day 1
Maximum postoperative pain using the visual analogue scale
8 secondary outcomes
Operation time
Time frame: Time during operation
Estimated blood loss
Time frame: During operation
Early postoperative complication
Time frame: within 30 days from the operation
Hospital stay
Time frame: Days until discharge
Time to first flatus
Time frame: Days until first flatus
Time to first soft fluid diet
Time frame: Days until first soft fluid diet
Maximum pain scores using VAS
Time frame: From postoperative day 0 to 5
EORTC-C30 and STO22
Time frame: Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months 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 6 Sep 2022.
Related trials for Early Gastric Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingObservational study
68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis
Medullary Thyroid Carcinoma, Small Cell Lung Cancer ( SCLC )
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Active, not recruitingObservational study
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
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.
Sang-Hoon Ahn, M.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach Method in people with Early Gastric Cancer, run by Seoul National University Bundang 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 2 inclusion and 2 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 6 Sep 2022. 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?
Maximum pain score using VAS at postoperative day#1 (time frame: Postoperative day 1). 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 6 Sep 2022.