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Kombineret endoskopisk-laparoskopisk Sentinel Lymfeknude Navigationskirurgi ved tidlig gastrisk cancer (FLECSS)

19. august 2026 opdateret af: Beijing Friendship Hospital

Kombineret endoskopisk-laparoskopisk Sentinel Lymfeknude Navigation Surgery i tidlig gastrisk cancer: en multicenter randomiseret kontrolleret undersøgelse

Den vigtigste behandling af tidlig gastrisk kræft (EGC) inkluderer endoskopisk submucosal dissektion (ESD) og radikal gastrektomi. Imidlertid forbliver passende behandling for patienter, der overskrider de absolutte indikationer og ikke -kurativ resektion af ESD, ikke -etableret. Kombineret endoskopisk-laparoskopisk Sentinel-knudepunktnavigation ser ud til at være den lovende løsning i henhold til tidligere undersøgelse, men evidensbaseret medicin i Kina manglede. Det er bydende nødvendigt at etablere dens sikkerhed og effektivitet hos kinesiske patienter med EGC.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Den primære behandling for tidlig mavekræft (EGC) inkluderer endoskopisk submukosadissektion (ESD) og radikal gastrektomi. Imidlertid er passende behandling for patienter, der overskrider de absolutte indikationer og ikke-kurative resektioner ved ESD, stadig ikke etableret. Sentinelknude-navigationskirurgi (SNNS) muliggør begrænset lymfeknuderesektion, hvilket letter funktionsbevarende gastrektomi (FPG) og forbedrer livskvalitet (QoL). Ifølge tidligere undersøgelser ser SNNS ud til at være den lovende løsning, men der manglede evidensbaseret medicin. Det er afgørende at etablere dens sikkerhed og effektivitet hos patienter med EGC. Imidlertid er den optimale implementering af FPG stadig uklar. Desuden er objektiv vurdering af postoperative funktionelle resultater stadig begrænset.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

312

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100050
        • Rekruttering
        • Beijing Friendship Hospital, Capital Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inkluderingskriterier:

  • 1) Patienter i alderen 18-80 år, uanset køn. 2) Patienter med Eastern Cooperative Oncology Group (ECOG) score ≤ 2 og American Society of Anesthesiologists (ASA) score ≤ 2, der er kandidater til en helbredende D2 gastrektomi.

    3) Patienter uden forudgående gastrointestinal kirurgi, kemoterapi eller strålebehandling.

    4) Patienter med normal lever-, nyre-, hjerte-, lunge- og knoglemarvsfunktion (GPT × 109 /L, PLT>109 /L).

    5) Patienter, der er i stand til at forstå og overholde forskningsprotokollen. 6) Patienter, der kan give skriftligt informeret samtykke, enten personligt eller gennem juridisk repræsentant.

    7) Patienter med CT1NXM0 gastrisk kræft eller efter ikke-kurativ ESD-resektion, ifølge UICC TNM iscenesættelsessystem, 8. udgave.

Ekskluderingskriterier:

  • 1) Patienter med kontraindikation for gastroskopi. 2) Patienter med ukontrollerbare sygdomme, såsom koagulationsforstyrrelser, epilepsi, sygdomme i centralnervesystemet eller psykiske lidelser, hjerte-lunge-insufficiens, ustabil angina, myokardieinfarkt, en cerebrovaskulær ulykke, der opstod inden for 6 måneder, og andre kirurgiske kontraindikationer.

    3) Patienter, der ikke er i stand til at gennemgå generel anæstesi eller kirurgisk behandling på grund af tilstande relateret til andre organer, eller uvillige til at gennemgå operation.

    4) Patienter med gastrisk stumpcancer, tilbagevendende mavecancer, multiple primære maligne tumorer i bughulen eller en historie med andre ondartede tumorer inden for de foregående 5 år.

    5) Gravide eller ammende kvinder. 6) Deltagere tilmeldte sig andre kliniske forsøg. 7) Patienter med ubestridelig sporstoffarvningsområde eller kontraindikationer til sporingsanvendelse.

    8) Patienter, der ikke modtager eller fejler ESD-behandling. 9) Patienter, der opfylder den absolutte indikation af ESD.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: D2 gastrektomi
En præoperativ kontrastforbedret abdominal CT-scanning udføres for at vurdere læsionens placering, tumordimensioner og lymfeknude-metastase (LNM). Preoperativ endoskopisk farvestofinjektion eller intraoperativ endoskopisk lokalisering anvendes til nøjagtigt at identificere tumorstedet og sikre tilstrækkelige resektionsmargener. Omfanget af lymfeknude -dissektion (LND) klæber til de japanske retningslinjer for gastrisk kræftbehandling 2023 (6. udgave) [4]. Specifikt omfatter D2 distal gastrektomi lymfeknuder nr. 1, 3, 4SB, 4D, 5, 6, 7, 8a, 9, 11p og 12a. D2 proximal gastrektomi inkluderer knudepunkter 1, 2, 3a, 4SA, 4SB, 7, 8a, 9, 11p og 12a, mens d2 total gastrektomi involverer knudepunkter 1, 2, 3, 4SA, 4SB, 4D, 5, 6, 7, 7, 8a, 9, 11p, 11d og 12a.
Procedure: Laparoskopisk D2 radikal gastrektomi
Forberedelse: Patienten lægges på ryggen med generel anæstesi. En orogastrisk sonde og Foley-kateter indsættes. Antibiotika administreres, og sekventielle strømper påføres. Portplacering: Pneumoperitoneum skabes via en Veress-nål ved navlen. Arbejdsporte er placeret i de øvre kvadranter med en femte port til levertilbagetrækning. Abdominal Exploration: Abdomen inspiceres for metastaser, og der udføres peritoneal cytologi. Dissektion og fjernelse af lymfeknuder: Det mindre omentum er delt nær leveren og når cardia og mellemgulv. Det gastrokoliske ledbånd er delt langs den tværgående tyktarm. Lymfeknudedissektion begynder langs miltarterien og fortsætter derefter til venstre gastriske arterie og cøliaki. De venstre gastriske kar kontrolleres med endoclips.Efter lymfeknudedissektion udføres distal subtotal gastrectomy. Rekonstruktion af fordøjelseskanalen sker typisk gennem en mini-laparotomi.
Eksperimentel: Fluorescensstyret laparoskopisk-endoskopisk kooperativ sentinel lymfeknude navigationskirurgi-strat
Laparoskopisk-endoskopisk kooperativ kirurgi (LECS) tilbyder en mere målrettet tilgang gennem integrationen af de komplementære styrker ved endoskopi og laparoskopi. LECS muliggør præcis målretning, optimale resektionsmarginer og vævsbesparende ekscision. Som følge heraf bevarer LECS mavens arkitektur og funktion bedre, hvilket potentielt fører til forbedret postoperativ restitution og livskvalitet. Alligevel forbliver den nuværende evidens, der støtter LECS for SNNS, begrænset.
Procedure: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery

Patients without prior ESD received ESD with laparoscopic sentinel basin dissection (LSBD) for ESD resectable lesions, otherwise patients received laparoscopic-endoscopic cooperative regional gastrectomy (LRG) with LSBD. For patients with prior non-curative ESD, LSBD alone was performed if margins were negative, otherwise LRG with LSBD was conducted. Intraoperative frozen-section pathological examination of the horizontal resection margin of the ESD or full-thickness specimen.

During laparoscopic sentinel node basin dissection (LSBD), indocyanine green (ICG) (2 mL, 2.5 mg/mL) was endoscopically injected into the submucosal layer at four quadrants around the marking points (0.5 mL per quadrant). Fifteen minutes after ICG injection, sentinel lymph node basins (SLBs) were defined as the area within a 2 cm margin of the detected fluorescence stained nodes, which were marked with laparoscopic clips.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3-year disease-free survival (DFS) rate
Tidsramme: From date of surgery to up to 3 years post-surgery
DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause.
From date of surgery to up to 3 years post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Hospitalization Cost
Tidsramme: From the time of admission to the time of discharge, assessed up to 3 weeks
From the time of admission to the time of discharge, assessed up to 3 weeks
5-year disease-free survival (DFS) rate
Tidsramme: From date of surgery to up to 5 years post-surgery
DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause.
From date of surgery to up to 5 years post-surgery
3-year overall survival (OS) rate
Tidsramme: From date of surgery to up to 3 years post-surgery
OS is defined as the time from the date of surgery to death from any cause.
From date of surgery to up to 3 years post-surgery
5-year overall survival (OS) rate
Tidsramme: From date of surgery to up to 5 years post-surgery
OS is defined as the time from the date of surgery to death from any cause.
From date of surgery to up to 5 years post-surgery
3-year recurrence-free survival (RFS) rate
Tidsramme: From date of surgery to up to 3 years post-surgery
RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence.
From date of surgery to up to 3 years post-surgery
5-year recurrence-free survival (RFS) rate
Tidsramme: From date of surgery to up to 5 years post-surgery
RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence.
From date of surgery to up to 5 years post-surgery
3-year disease-specific survival (DSS) rate
Tidsramme: From date of surgery to up to 3 years post-surgery
DSS is defined as the length of time that the patients survived from the time of randomization or treatment initiation until death from the specific disease in question.
From date of surgery to up to 3 years post-surgery
5-year disease-specific survival (DSS) rate
Tidsramme: From date of surgery to up to 5 years post-surgery
DSS is defined as the length of time that the patients survived from the time of randomization or treatment initiation until death from the specific disease in question
From date of surgery to up to 5 years post-surgery
3-year progression-free survival (PFS) rate
Tidsramme: From date of surgery to up to 3 years post-surgery
PFS is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease.
From date of surgery to up to 3 years post-surgery
5-year progression-free survival (PFS) rate
Tidsramme: From date of surgery to up to 5 years post-surgery
PFS is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease.
From date of surgery to up to 5 years post-surgery
30-day postoperative mortality
Tidsramme: From the date of surgery to 30 days post-surgery
All-cause mortality occurring within 30 days after surgery.
From the date of surgery to 30 days post-surgery
30-day postoperative morbidity
Tidsramme: From the date of surgery to 30 days post-surgery
Postoperative complications occurring within 30 days will be recorded, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula, according to the Clavien-Dindo scale
From the date of surgery to 30 days post-surgery
Unscheduled Second Surgery Rate
Tidsramme: From the date of surgery to 30 days post-surgery
Rate of unscheduled reoperation within 30 days after the initial surgery
From the date of surgery to 30 days post-surgery
Unplanned Return to Hospital Rate
Tidsramme: From the date of surgery to 30 days post-surgery
Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery
From the date of surgery to 30 days post-surgery
Rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine
Tidsramme: From the date of surgery to 7 days post-surgery
From the date of surgery to 7 days post-surgery
Operation time
Tidsramme: At the time of surgery
At the time of surgery
Operation method
Tidsramme: At the time of surgery
At the time of surgery
R0 resection rate
Tidsramme: From date of surgery to 7 days post-surgery
Proportion of patients with no residual tumor microscopically confirmed on both the primary tumor resection margins and resected lymph nodes, assessed by postoperative pathological examination.
From date of surgery to 7 days post-surgery
Remedial and additional surgery rate
Tidsramme: From the date of surgery to 30 days post-surgery
Proportion of patients requiring additional surgical procedures due to intraoperative or postoperative pathological findings
From the date of surgery to 30 days post-surgery
Intraoperative Blood Loss
Tidsramme: At the time of surgery
Estimated total volume of blood loss during the surgical procedure
At the time of surgery
Postoperative Length of Stay
Tidsramme: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Total number of days from the date of surgery to hospital discharge
From date of surgery until date of hospital discharge, assessed up to 2 weeks
Average Length of Stay
Tidsramme: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Average number of days from the date of surgery to hospital discharge
From date of surgery until date of hospital discharge, assessed up to 2 weeks
Gastric Emptying Scintigraphy
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
From 30 days prior to surgery to 5 years post-surgery
Time to First Flatus
Tidsramme: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Time from the date of surgery to the first passage of flatus, indicating recovery of gastrointestinal motility.
From date of surgery until date of hospital discharge, assessed up to 2 weeks
Serum Total Protein
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
From 30 days prior to surgery to 5 years post-surgery
Albumin
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
From 30 days prior to surgery to 5 years post-surgery
Hemoglobin
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
From 30 days prior to surgery to 5 years post-surgery
Prealbumin
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
From 30 days prior to surgery to 5 years post-surgery
Prognostic Nutritional Index (PNI)
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
It is a combined score based on serum albumin level and total lymphocyte count. It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL). Higher scores indicate better nutritional and immunological status.
From 30 days prior to surgery to 5 years post-surgery
Postoperative gastroscopy composite adverse findings
Tidsramme: From date of surgery to up to 5 years post-surgery
Proportion of participants with any of the following adverse findings on surveillance endoscopy: poor anastomotic healing, residual lesions, metachronous lesions, or local recurrence. Participants are counted once if they meet any of these criteria.
From date of surgery to up to 5 years post-surgery
Postoperative CT composite findings
Tidsramme: From date of surgery to up to 5 years post-surgery
Proportion of participants with any of the following adverse findings on contrast-enhanced CT of the chest, abdomen, and pelvis: local recurrence, distant metastasis, or abnormal lymph nodes.
From date of surgery to up to 5 years post-surgery
Postoperative histopathological composite findings
Tidsramme: From date of surgery to up to 5 years post-surgery
Proportion of participants with positive findings for malignancy on histopathological examination of biopsy specimens obtained during scheduled follow-up endoscopy or additional surgery.
From date of surgery to up to 5 years post-surgery
EORTC QLQ-C30
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
From 30 days prior to surgery to 5 years post-surgery
EORTC QLQ-STO22
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.
From 30 days prior to surgery to 5 years post-surgery
PGSAS-45
Tidsramme: From 30 days prior to surgery to 5 years post-surgery
The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions. All subscale scores are linearly transformed to a 0-100 range. For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life.
From 30 days prior to surgery to 5 years post-surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Friendship Hospital

Samarbejdspartnere

China-Japan Friendship Hospital
Cancer Hospital Chinese Academy of Medical Scienc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. februar 2024

Primær færdiggørelse (Anslået)

1. november 2029

Studieafslutning (Anslået)

30. december 2029

Datoer for studieregistrering

Først indsendt

16. december 2024

Først indsendt, der opfyldte QC-kriterier

21. januar 2025

Først opslået (Faktiske)

23. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BRWEP2024W162020112 (Andet bevillings-/finansieringsnummer: Beijing Research Ward Excellence Program, BRWEP)
  • 82300646 (Andet bevillings-/finansieringsnummer: National Natural Science Foundation of China)
  • 7232334 (Andet bevillings-/finansieringsnummer: Beijing Natural Science Foundation)
  • D171100006517003 (Andet bevillings-/finansieringsnummer: Beijing Municipal Science & Technology Commission)
  • PX2020001 (Andet bevillings-/finansieringsnummer: Beijing Municipal Administration of Hospitals Incubating Program)
  • PX20240103 (Andet bevillings-/finansieringsnummer: Beijing Municipal Administration of Hospitals Incubating Program)
  • No.2024-2-2028 (Andet bevillings-/finansieringsnummer: Capital's Funds for Health Improvement and Research)
  • Z241100007724004 (Andet bevillings-/finansieringsnummer: Beijing Municipal Science & Technology Commission AI+ Health Collaborative Innovation Cultivation Project)
  • BRWEP2024W162020100 (Andet bevillings-/finansieringsnummer: Beijing Research Ward Excellence Program, BRWEP)
  • YC202401QX0824 (Andet bevillings-/finansieringsnummer: Excellent Plan for Medicine Innovation and Translation project)
  • [ZHKY-2025-1869（B012）] (Andet bevillings-/finansieringsnummer: Beijing Integrated Medical Association Clinical Research Funding Program)
  • No.2024ZD0520600 (Andet bevillings-/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project Award)

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