Laparoscopic-endoscopic Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
10. september 2026 oppdatert av: Dong Yang, Jilin University
A Prospective Registry Study of Laparoscopic-endoscopic Cooperative Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
This study is to evaluate the safety and efficacy of dual-endoscope assisted sentinel lymph node navigation surgery for early gastric cancer (EGC).
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Quan Wang, Professor
- Telefonnummer: 15843073207
- E-post: wquan@jlu.edu.cn
Studiesteder
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- Rekruttering
- The First Hospital of Jilin University
-
Ta kontakt med:
- Quan Wang, Professor
- Telefonnummer: 86-15843073207
- E-post: wquan@jlu.edu.cn
-
Ta kontakt med:
- E-post: yang_dong@jlu.edu.cn
-
Ch’ang-ch’un, Jilin, Kina, 130021
- Aktiv, ikke rekrutterende
- The First Hospital of Jilin University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Preoperative assessment indicating that the tumor was confined to the mucosa or submucosa, consistent with the diagnosis of early gastric cancer.
- Patients who required additional surgical intervention following initial endoscopic submucosal dissection (ESD) based on postoperative pathological evaluation.
- Patients and their families fully understood the procedure, requested dual-endoscope assisted sentinel lymph node navigation surgery, agreed to participate in this clinical study, and signed the informed consent form.
Exclusion Criteria:
- Preoperative assessment indicating suspected lymph node or distant metastasis.
- History of complex abdominal surgery rendering laparoscopic treatment infeasible.
- Participation in another clinical trial within 4 weeks prior to enrollment or currently participating in another trial.
- History of severe psychiatric disorders.
- Pregnant or lactating women.
- Uncontrolled infection prior to surgery.
- Presence of other malignancies or comorbidities that may significantly affect survival.
- Any other conditions deemed by the investigators as unsuitable for participation, or refusal by the patient or family to enroll.
- Cardiopulmonary, hepatic, and renal functions were unsufficient to tolerate the surgery.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sentinel Lymph Node Navigation Surgery
Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
|
After preoperative assessment and confirmation of eligibility, patients received general anesthesia with endotracheal intubation.
Indocyanine green (ICG) was injected submucosally around the lesion in four quadrants to trace the sentinel lymph node (SLN) basin.
Laparoscopic marking of the SLN basin was performed.
Endoscopy assisted laparoscopy in marking the primary lesion border (ensuring a margin of >0.5 cm).
Laparoscopic sentinel lymph node dissection was performed, followed by endoscopic/laparoscopic full-thickness resection of the lesion.
Gastric wall defects were closed laparoscopically.
SLNs were harvested and sent for intraoperative frozen section pathology.
If positive, a standard radical gastrectomy was performed; if negative, an abdominal drainage tube was placed to complete the procedure.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of perioperative complications.
Tidsramme: One month after surgery
|
Postoperative complications comprised hemorrhage, obstruction, gastrointestinal motility disorders, and fistulas.
The overall complication rate was calculated as the number of patients with complications divided by the total number of patients in the cohort.
|
One month after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of retrieved lymph nodes.
Tidsramme: One week after the surgery.
|
The number of lymph nodes retrieved from all resected specimens.
|
One week after the surgery.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
R0 resection rate
Tidsramme: One month after surgery.
|
The R0 resection rate was defined as the proportion of patients with histopathologically confirmed complete resection and negative margins among all enrolled patients.
|
One month after surgery.
|
|
Number of patients requiring further therapy
Tidsramme: Three month after surgery.
|
Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).
|
Three month after surgery.
|
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the number of postoperative hospital stay in days.
Tidsramme: One month after the surgery.
|
Time from surgery to discharge was recorded in days.
|
One month after the surgery.
|
|
the number of time to first resumption of liquid diet in days
Tidsramme: One month after surgery.
|
Time to first resumption of liquid diet was recorded in days.
|
One month after surgery.
|
|
the total number of Hospitalization costs in Chinese Yuan (CNY).
Tidsramme: One month after surgery.
|
Total hospitalization costs were calculated in Chinese Yuan (CNY).
|
One month after surgery.
|
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the rate of positive cytological examination results of peritoneal lavage fluid.
Tidsramme: One week after surgery.
|
Cytological examination of the irrigation fluid from the surgical field was performed postoperatively.
A finding of tumor cells was considered positive.
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One week after surgery.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. mai 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 130019
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