NCT07295002

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
42mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Oct 2029

First Submitted

Initial submission to the registry

November 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

November 15, 2025

Last Update Submit

December 15, 2025

Conditions

Early Gastric Cancer

Keywords

sentinel node-resectionminimal invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Severe complications defined as Clavien-Dindo >/= III

    Safety of the procedure, defined as Clavien-Dindo complication grade \>/= III

    Periprocedural

Secondary Outcomes (14)

  • Any complications

    Periprocedural

  • Postoperative bleeding

    Periprocedural

  • Leakage

    Periprocedural

  • Operation time

    Periprocedural

  • Pathological tumor (T)-stage

    Up to 2 months post procedure

  • +9 more secondary outcomes

Study Arms (1)

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

Procedure: ICG-guided lymphadenectomyProcedure: Laparoscopic and endoscopic cooperative surgery (LECS)

Interventions

ICG-guided lymphadenectomyPROCEDURE

Submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes

ICG-guided lymphadenectomy +/- LECS
Laparoscopic and endoscopic cooperative surgery (LECS)PROCEDURE

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.

ICG-guided lymphadenectomy +/- LECS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital Huddinge

Stockholm, 141 57, Sweden

Location

Related Publications (9)

  • 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.

    PMID: 35836598BACKGROUND

  • Morais 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.

    PMID: 37666656BACKGROUND

  • van 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.

    PMID: 32818901BACKGROUND

  • Tsekrekos 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.

    PMID: 36808262BACKGROUND

  • Nevo 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.

    PMID: 29761671BACKGROUND

  • Wang 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.

    PMID: 30560498BACKGROUND

  • Japanese 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.

    PMID: 36342574BACKGROUND

  • Pimentel-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.

    PMID: 35523224BACKGROUND

  • Murakami T. Early cancer of the stomach. World J Surg. 1979 Nov;3(6):685-92. doi: 10.1007/BF01654788. No abstract available.

    PMID: 532187BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ioannis Rouvelas, MD, PhD

    ME Övre buk, Karolinska Universitetssjukhuset

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioannis Rouvelas, MD, PhD

CONTACT

+46707976814ioannis.rouvelas@ki.se

Henrik Maltzman, MD

CONTACT

+46706334445henrik.maltzman@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

November 15, 2025

First Posted

December 19, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)