Laparoscopic-endoscopic Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
10 september 2026 uppdaterad 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).
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Quan Wang, Professor
- Telefonnummer: 15843073207
- E-post: wquan@jlu.edu.cn
Studieorter
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- Rekrytering
- The First Hospital of Jilin University
-
Kontakt:
- Quan Wang, Professor
- Telefonnummer: 86-15843073207
- E-post: wquan@jlu.edu.cn
-
Kontakt:
- E-post: yang_dong@jlu.edu.cn
-
Ch’ang-ch’un, Jilin, Kina, 130021
- Aktiv, inte rekryterande
- The First Hospital of Jilin University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of perioperative complications.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of retrieved lymph nodes.
Tidsram: One week after the surgery.
|
The number of lymph nodes retrieved from all resected specimens.
|
One week after the surgery.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
R0 resection rate
Tidsram: 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
Tidsram: Three month after surgery.
|
Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).
|
Three month after surgery.
|
|
the number of postoperative hospital stay in days.
Tidsram: 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
Tidsram: 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).
Tidsram: One month after surgery.
|
Total hospitalization costs were calculated in Chinese Yuan (CNY).
|
One month after surgery.
|
|
the rate of positive cytological examination results of peritoneal lavage fluid.
Tidsram: 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.
|
One week after surgery.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 maj 2026
Primärt slutförande (Beräknad)
31 december 2028
Avslutad studie (Beräknad)
31 december 2029
Studieregistreringsdatum
Först inskickad
22 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 130019
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