Early Gastric CancerCo-SNARENCT07295002
Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC
A study testing ICG-guided lymphadenectomy and Laparoscopic and endoscopic cooperative surgery (LECS) in people with Early Gastric Cancer, run by Region Stockholm at 1 site in Sweden.
Trial summary
For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- ICG-guided lymphadenectomy and Laparoscopic and endoscopic cooperative surgery (LECS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2026to 1 Oct 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EGC previously treated with ESD according to current guidelines (differentiated adenocarcinoma, not ulcerative, of any size, differentiated adenocarcinoma ulcerative </=3cm, undifferentiated adenocarcinoma not ulcerative </=2cm)
- Non curative resection
- Lymphovascular invasion
- Non-radical resection vertical margin
- deep submucosal invasion
- Signed informed consent
Who cannot join
- Location within 2 cm from cardia or pylorus
- Non-curative resection with only non-radicality horizontal margin
- Inoperative because of severe comorbidities
- Previous radiotherapy to the upper abdomen
- Pregnancy
- Allergy to ICG
- Inability to provide informed consent due to cognitive impairment, language barrier, or other reasons impairing understanding and autonomous decision-making.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska University Hospital Huddinge
Stockholm, 141 57
Ioannis Rouvelas, MD PhD, +46707976814, ioannis.rouvelas@regionstockholm.se
Henrik Maltzman, MD, +46706334445, henrik.maltzman@regionstockholm.se
About this study
Official title: COmpletion Sentinel Node Resection With or Without Minimally invAsive and Endoscopic Cooperative Surgery Following noncuRative Endoscopic Submucosal Dissection for Early Gastric Cancer
For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy with or without laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive alternative in such cases. For patients with a primary radically resected EGC, ICG-guided lymphadenectomy alone will be performed. For patients with deep-margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed, in order to ensure both local tumor control in the stomach and in regional nodes.
Read the detailed description
Endoscopic submucosal dissection (ESD) is the recommended treatment for early gastric cancer (EGC) who are fullfillling the criteria based on international guidelines. After ESD, some resections are classified as non-curative because of factors such as non radicality (especially when the deep margin is positive for cancer), lymphovascular invasion or deep submucosal invasion Sm>1. In such cases, guidelines recommend complementary gastrectomy and lymphadenectomy. Gastrectomy is known to carry a risk for severe complications in about 9-22 % of cases. Furthermore, up to 2/3 of patients are found to have no remaining tumor in the stomach or regional nodes after surgery.
In this trial, Indocyanine Green (ICG)-guided lymphadenectomy including sentinel node resection, with or without complementary laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive treatment option. For patients with radically resected EGC, ICG-guided lymphadenectomy alone will be performed. In patients with deep margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed.
ICG-guided lymphadenectomy is performed by first injecting 100 times diluted ICG in four quadrants in the submucosa around the tumor scar with gastroscopy. After 15 minutes, the draining nodes will be visualized with laparoscopy, and locally resected. LECS is performed by endoscopic marking of the scar followed circumferential mucosal cutting, trimming, and perforation of the stomach followed by full-thickness resection of the scar with laparoscopy. After resection, the resected specimen will be taken out and the stomach defect sutured laparoscopically.
After the procedure, the patient will be presented at a multidisciplinary tumor board. If only clinical follow-up is recommended, the patient will be followed closely with gastroscopy and computer tomography (CT) scan every 3 months for the first year.
- Conditions
- Early Gastric Cancer
- Being tested
- ICG-guided lymphadenectomy, Laparoscopic and endoscopic cooperative surgery (LECS)
- Keywords
- sentinel node-resection, minimal invasive surgery
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-guided lymphadenectomyProcedure or surgery
Submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes
Laparoscopic and endoscopic cooperative surgery (LECS)Procedure or surgery
Endoscopic marking and submucosal cutting around the scar after ESD, followed by perforation of the gastric wall and laparoscopic full thickness resection of the area under endoscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| ICG-guided lymphadenectomy +/- LECS | Experimental | Laparoscopic and endoscopic cooperative surgery to locally resect the gastric scar. This method will we be used for cases where pathology showed positive vertical margin after ESD. Otherwise, submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes Receives: Procedure: ICG-guided lymphadenectomy; Procedure: Laparoscopic and endoscopic cooperative surgery (LECS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complications defined as Clavien-Dindo >/= III
Safety of the procedure, defined as Clavien-Dindo complication grade >/= III
Measured: Periprocedural
Secondary outcomes (14)
Any complications
Any complication during the procedure (Clavien-Dindo II-IV)
Measured: Periprocedural
Postoperative bleeding
Postoperative bleeding requiring blood transfusion
Measured: Periprocedural
Leakage
Leakage/postoperative abscess requiring drainage
Measured: Periprocedural
Operation time
Time of the surgical procedure
Measured: Periprocedural
Pathological tumor (T)-stage
Depth of tumor invasion into the gastric wall (for LECS cases)
Measured: Up to 2 months post procedure
Tumor-free resection margins
The rate of horizontal and vertical margins free of tumor cells (for LECS cases).
Measured: Up to 2 months post procedure
Number of lymph nodes
Number of lymph nodes harvested during the procedure
Measured: Periprocedural
Number of positive lymph nodes
Number of lymph nodes positive for cancer
Measured: Up to 2 months post procedure
Hospital-stay
Number of days from the procedure until discharge
Measured: From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure
Health-related quality of life (HQL) score QLQ-30
Pre and postoperative HQL, tested with the validated score QLQ-C30 (The EORTC QLG Core Questionnaire for cancer patients)
Measured: Preoperatively, after 30 days and 1 year
Health-related quality of life (HQL) score OG25
Pre and postoperative HQL, tested with the validated score OG25 (The EORTC QLG Module Questionnaire specifically for esophago-gastric patients)
Measured: Preoperatively, after 30 days and 1 year
30-day mortality
30-day mortality
Measured: From procedure to maximum 30 days postoperatively
In-hospital mortality
In-hospital mortality
Measured: From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure
1-year disease-free survival
1-year disease-free survival
Measured: Until 1 year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Early 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ioannis Rouvelas, Region Stockholm
- Investigators
- Ioannis Rouvelas, MD, PhD, Principal investigator, ME Övre buk, Karolinska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295002
- Sponsor's protocol ID
- 2025-05956-01
- Other IDs
- 2025
- Acronym
- Co-SNARE
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belia F, Biondi A, Agnes A, Santocchi P, Laurino A, Lorenzon L, Pezzuto R, Tirelli F, Ferri L, D'Ugo D, Persiani R. The Use of Indocyanine Green (ICG) and Near-Infrared (NIR) Fluorescence-Guided Imaging in Gastric Cancer Surgery: A Narrative Review. Front Surg. 2022 Jun 28;9:880773. doi: 10.3389/fsurg.2022.880773. eCollection 2022.
PubMed 35836598Morais R, Libanio D, Dinis Ribeiro M, Ferreira A, Barreiro P, Bourke MJ, Gupta S, Amaro P, Kuttner Magalhaes R, Cecinato P, Boal Carvalho P, Pinho R, Rodriguez de Santiago E, Sferrazza S, Lemmers A, Figueiredo M, Pioche M, Gallego F, Albeniz E, Ramos Zabala F, Uchima H, Berr F, Wagner A, Marques M, Pimentel-Nunes P, Goncalves M, Mascarenhas A, Soares EG, Xavier S, Faria-Ramos I, Sousa-Pinto B, Gullo I, Carneiro F, Macedo G, Santos-Antunes J. Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score. Gut. 2023 Dec 7;73(1):105-117. doi: 10.1136/gutjnl-2023-330804.
PubMed 37666656van den Boorn HG, Stroes CI, Zwinderman AH, Eshuis WJ, Hulshof MCCM, van Etten-Jamaludin FS, Sprangers MAG, van Laarhoven HWM. Health-related quality of life in curatively-treated patients with esophageal or gastric cancer: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2020 Oct;154:103069. doi: 10.1016/j.critrevonc.2020.103069. Epub 2020 Aug 5.
PubMed 32818901Tsekrekos A, Vossen LE, Lundell L, Jeremiasen M, Johnsson E, Hedberg J, Edholm D, Klevebro F, Nilsson M, Rouvelas I. Improved survival after laparoscopic compared to open gastrectomy for advanced gastric cancer: a Swedish population-based cohort study. Gastric Cancer. 2023 May;26(3):467-477. doi: 10.1007/s10120-023-01371-8. Epub 2023 Feb 19.
PubMed 36808262Nevo Y, Goldes Y, Barda L, Nadler R, Gutman M, Nevler A. Risk Factors for Complications of Total/Subtotal Gastrectomy for Gastric Cancer: Prospectively Collected, Based on the Clavien-Dindo Classification System. Isr Med Assoc J. 2018 May;20(5):277-280.
PubMed 29761671Wang WJ, Li HT, Yu JP, Su L, Guo CA, Chen P, Yan L, Li K, Ma YW, Wang L, Hu W, Li YM, Liu HB. Severity and incidence of complications assessed by the Clavien-Dindo classification following robotic and laparoscopic gastrectomy for advanced gastric cancer: a retrospective and propensity score-matched study. Surg Endosc. 2019 Oct;33(10):3341-3354. doi: 10.1007/s00464-018-06624-7. Epub 2018 Dec 17.
PubMed 30560498Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25. doi: 10.1007/s10120-022-01331-8. Epub 2022 Nov 7.
PubMed 36342574Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6.
PubMed 35523224Murakami T. Early cancer of the stomach. World J Surg. 1979 Nov;3(6):685-92. doi: 10.1007/BF01654788. No abstract available.
PubMed 532187
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmpletion Sentinel Node Resection With or Without Minimally invAsive and Endoscopic Cooperative Surgery Following noncuRative Endoscopic Submucosal Dissection for Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT07295002
- Acronym / sponsor ID
- Co-SNARE / 2025-05956-01
- Conditions
- Early Gastric Cancer
- Keywords
- sentinel node-resection, minimal invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 19 Dec 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.
For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy with or without laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive alternative in such cases. For patients with a primary radically resected EGC, ICG-guided lymphadenectomy alone will be performed. For patients with deep-margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed, in order to ensure both local tumor control in the stomach and in regional nodes.
Detailed description
Endoscopic submucosal dissection (ESD) is the recommended treatment for early gastric cancer (EGC) who are fullfillling the criteria based on international guidelines. After ESD, some resections are classified as non-curative because of factors such as non radicality (especially when the deep margin is positive for cancer), lymphovascular invasion or deep submucosal invasion Sm>1. In such cases, guidelines recommend complementary gastrectomy and lymphadenectomy. Gastrectomy is known to carry a risk for severe complications in about 9-22 % of cases. Furthermore, up to 2/3 of patients are found to have no remaining tumor in the stomach or regional nodes after surgery.
In this trial, Indocyanine Green (ICG)-guided lymphadenectomy including sentinel node resection, with or without complementary laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive treatment option. For patients with radically resected EGC, ICG-guided lymphadenectomy alone will be performed. In patients with deep margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed.
ICG-guided lymphadenectomy is performed by first injecting 100 times diluted ICG in four quadrants in the submucosa around the tumor scar with gastroscopy. After 15 minutes, the draining nodes will be visualized with laparoscopy, and locally resected. LECS is performed by endoscopic marking of the scar followed circumferential mucosal cutting, trimming, and perforation of the stomach followed by full-thickness resection of the scar with laparoscopy. After resection, the resected specimen will be taken out and the stomach defect sutured laparoscopically.
After the procedure, the patient will be presented at a multidisciplinary tumor board. If only clinical follow-up is recommended, the patient will be followed closely with gastroscopy and computer tomography (CT) scan every 3 months for the first year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG-guided lymphadenectomy +/- LECS | Experimental | Procedure: ICG-guided lymphadenectomy, Procedure: Laparoscopic and endoscopic cooperative surgery (LECS)Laparoscopic and endoscopic cooperative surgery to locally resect the gastric scar. This method will we be used for cases where pathology showed positive vertical margin after ESD. Otherwise, submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- EGC previously treated with ESD according to current guidelines (differentiated adenocarcinoma, not ulcerative, of any size, differentiated adenocarcinoma ulcerative </=3cm, undifferentiated adenocarcinoma not ulcerative </=2cm)
- Non curative resection
- Signed informed consent
Key exclusion criteria (7 listed)
- Location within 2 cm from cardia or pylorus
- Non-curative resection with only non-radicality horizontal margin
- Inoperative because of severe comorbidities
- Previous radiotherapy to the upper abdomen
- Pregnancy
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 |
|---|---|---|
| ICG-guided lymphadenectomySubmucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes | Procedure or surgery | ICG-guided lymphadenectomy +/- LECS |
| Laparoscopic and endoscopic cooperative surgery (LECS)Endoscopic marking and submucosal cutting around the scar after ESD, followed by perforation of the gastric wall and laparoscopic full thickness resection of the area under endoscopic guidance. | Procedure or surgery | ICG-guided lymphadenectomy +/- LECS |
Primary outcome
Severe complications defined as Clavien-Dindo >/= III
Time frame: Periprocedural
Safety of the procedure, defined as Clavien-Dindo complication grade >/= III
14 secondary outcomes
Any complications
Time frame: Periprocedural
Postoperative bleeding
Time frame: Periprocedural
Leakage
Time frame: Periprocedural
Operation time
Time frame: Periprocedural
Pathological tumor (T)-stage
Time frame: Up to 2 months post procedure
Tumor-free resection margins
Time frame: Up to 2 months post procedure
Number of lymph nodes
Time frame: Periprocedural
Number of positive lymph nodes
Time frame: Up to 2 months post procedure
Hospital-stay
Time frame: From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure
Health-related quality of life (HQL) score QLQ-30
Time frame: Preoperatively, after 30 days and 1 year
Health-related quality of life (HQL) score OG25
Time frame: Preoperatively, after 30 days and 1 year
30-day mortality
Time frame: From procedure to maximum 30 days postoperatively
In-hospital mortality
Time frame: From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure
1-year disease-free survival
Time frame: Until 1 year after the procedure
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 19 Dec 2025.
- Background: PubMed 35836598Belia F, Biondi A, Agnes A, Santocchi P, Laurino A, Lorenzon L, Pezzuto R, Tirelli F, Ferri L, D'Ugo D, Persiani R. The Use of Indocyanine Green (ICG) and Near-Infrared (NIR) Fluorescence-Guided Imaging in Gastric Cancer Surgery: A Narrative Review. Front Surg. 2022 Jun 28;9:880773. doi: 10.3389/fsurg.2022.880773. eCollection 2022.
- Background: PubMed 37666656Morais R, Libanio D, Dinis Ribeiro M, Ferreira A, Barreiro P, Bourke MJ, Gupta S, Amaro P, Kuttner Magalhaes R, Cecinato P, Boal Carvalho P, Pinho R, Rodriguez de Santiago E, Sferrazza S, Lemmers A, Figueiredo M, Pioche M, Gallego F, Albeniz E, Ramos Zabala F, Uchima H, Berr F, Wagner A, Marques M, Pimentel-Nunes P, Goncalves M, Mascarenhas A, Soares EG, Xavier S, Faria-Ramos I, Sousa-Pinto B, Gullo I, Carneiro F, Macedo G, Santos-Antunes J. Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score. Gut. 2023 Dec 7;73(1):105-117. doi: 10.1136/gutjnl-2023-330804.
- Background: PubMed 32818901van den Boorn HG, Stroes CI, Zwinderman AH, Eshuis WJ, Hulshof MCCM, van Etten-Jamaludin FS, Sprangers MAG, van Laarhoven HWM. Health-related quality of life in curatively-treated patients with esophageal or gastric cancer: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2020 Oct;154:103069. doi: 10.1016/j.critrevonc.2020.103069. Epub 2020 Aug 5.
- Background: PubMed 36808262Tsekrekos A, Vossen LE, Lundell L, Jeremiasen M, Johnsson E, Hedberg J, Edholm D, Klevebro F, Nilsson M, Rouvelas I. Improved survival after laparoscopic compared to open gastrectomy for advanced gastric cancer: a Swedish population-based cohort study. Gastric Cancer. 2023 May;26(3):467-477. doi: 10.1007/s10120-023-01371-8. Epub 2023 Feb 19.
- Background: PubMed 29761671Nevo Y, Goldes Y, Barda L, Nadler R, Gutman M, Nevler A. Risk Factors for Complications of Total/Subtotal Gastrectomy for Gastric Cancer: Prospectively Collected, Based on the Clavien-Dindo Classification System. Isr Med Assoc J. 2018 May;20(5):277-280.
- Background: PubMed 30560498Wang WJ, Li HT, Yu JP, Su L, Guo CA, Chen P, Yan L, Li K, Ma YW, Wang L, Hu W, Li YM, Liu HB. Severity and incidence of complications assessed by the Clavien-Dindo classification following robotic and laparoscopic gastrectomy for advanced gastric cancer: a retrospective and propensity score-matched study. Surg Endosc. 2019 Oct;33(10):3341-3354. doi: 10.1007/s00464-018-06624-7. Epub 2018 Dec 17.
- Background: PubMed 36342574Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25. doi: 10.1007/s10120-022-01331-8. Epub 2022 Nov 7.
- Background: PubMed 35523224Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6.
- Background: PubMed 532187Murakami T. Early cancer of the stomach. World J Surg. 1979 Nov;3(6):685-92. doi: 10.1007/BF01654788. No abstract available.
- 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.
Ioannis Rouvelas, MD, PhD principal investigator
ME Övre buk, Karolinska Universitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-guided lymphadenectomy and Laparoscopic and endoscopic cooperative surgery (LECS) in people with Early Gastric Cancer, run by Region Stockholm at 1 site in Sweden.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Dec 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 Sweden. 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 Ioannis Rouvelas, MD, PhD (+46707976814, ioannis.rouvelas@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe complications defined as Clavien-Dindo >/= III (time frame: Periprocedural). 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 NCT07295002, which also lists 9 linked publications.
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 19 Dec 2025.