- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07708012
Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer
Safety and Effectiveness of Laparoscopic Sentinel Lymph Node Navigation Combined With Dual-endoscope Surgery for Early Stomach Cancer: a Prospective, Single-centre, Single-arm Clinical Study
Gastric cancer is a common malignant tumour worldwide, and in China, the incidence and mortality rates of gastric cancer remain high. Standardised surgical treatment is effective, but the normal structure of the stomach undergoes irreversible changes, leading to a series of adverse reactions. At the same time, some early-stage gastric cancer patients cannot have the lesions completely removed endoscopically, and conventional surgery can affect postoperative normal life. Therefore, laparoscopic and endoscopic cooperative surgery has become a focus for precise stomach-preserving surgery. Participants meeting the surgical criteria are selected, and after discussing the treatment plan with their families and signing informed consent forms, relevant examinations are completed. During surgery, lesions are explored together using laparoscopy and endoscopy, then a fluorescent tracer is injected around the lesion and the lesion boundary is marked. Fifteen minutes after injecting the fluorescent tracer, the illuminated perigastric lymph nodes are the sentinel lymph node region (SLNB), and all fluorescent lymph nodes (sentinel lymph nodes) are removed and sent for intraoperative frozen pathology. If the SLNB is negative: a dual-endoscope combined local gastric resection (endoscope combined with laparoscopic local gastric resection or a modified procedure) is performed to completely remove the lesion, ensuring a negative margin. If the SLNB is positive: immediate conversion to laparoscopic-assisted radical gastrectomy (D2 lymph node dissection) is carried out. For SLNB-negative cases, the dual-endoscope combined local gastric resection specimen is placed in a retrieval bag for full removal and examination, with the stomach wall incision then closed by suturing or using a stapler. Postoperative follow-up includes monitoring tumour outcomes and quality of life.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Stomach cancer is one of the common malignant tumours worldwide, and in China, the incidence and mortality rates of stomach cancer remain high, posing a major public health burden. With the widespread implementation of stomach cancer screening in China, the detection rate of early-stage stomach cancer has significantly increased, now accounting for 19.5% of all stomach cancer cases. Early-stage stomach cancer (T1 stage) has a much better prognosis than advanced-stage cancer, with a 5-year survival rate exceeding 90% after standard treatment. Endoscopic submucosal dissection (ESD), due to its minimally invasive nature and ability to preserve stomach function, has become the standard treatment for certain cT1a-stage stomach cancers. However, for early-stage stomach cancer patients with a higher risk of lymph node metastasis, the lymph node metastasis rate can be close to 20%. In this context, if these patients only undergo endoscopic removal, they may face a higher risk of tumour residue. The traditional standard treatment is radical gastrectomy, usually combined with regional lymph node dissection (D1 or D2). Although this surgery is effective for cancer control, it can cause significant trauma, leading to irreversible changes to the patient's post-operative physiology and function, as well as long-term complications such as malnutrition, reflux oesophagitis and reduced quality of life, which have become key issues affecting the recovery of early-stage stomach cancer patients.
With the development of endoscopic technology (gastroscopy) and laparoscopic minimally invasive surgery, the concept of "function-preserving" surgery for early gastric cancer has been gaining increasing attention. This concept aims to minimise surgical trauma and preserve the anatomical structure and physiological function of the stomach while ensuring oncological safety. Achieving this goal relies heavily on the development and integration of two key techniques. First is Laparoscopic Sentinel Node Navigation Surgery (LSNNS). Sentinel lymph nodes are the first or group of lymph nodes along the primary tumour's lymphatic drainage pathway, and their pathological state is considered to highly predict metastasis in all lymph nodes in that region. In gastric cancer surgery, by injecting tracers (such as the fluorescent dye indocyanine green) under the mucosa around the tumour, and using the magnified view and fluorescence imaging system of laparoscopy, these sentinel lymph nodes can be located and removed in real time for intraoperative rapid pathological examination. The National Cancer Center in South Korea conducted a multicentre phase III randomised controlled clinical trial (SENORITA) on laparoscopic sentinel node navigation surgery for function-preserving surgery in early gastric cancer. In the LSNNS group, 210 patients (81%) underwent stomach-preserving surgery, and the results showed no significant difference in postoperative complication rates, 5-year local recurrence, disease-free survival (DFS), and overall survival (OS) compared to conventional laparoscopic radical gastrectomy. However, the LSNNS group had significantly better postoperative quality of life. These study results suggest that due to the complexity of gastric cancer lymphatic drainage and the skip and uncertain nature of metastasis, detecting the sentinel lymphatic basin (SLB) can provide a more comprehensive understanding of sentinel nodes, offering precise guidance for individualised lymph node dissection and avoiding unnecessary extended lymph node removal, reducing surgical trauma and related complications without compromising oncological outcomes.
Laparoscopic and endoscopic cooperative surgery (LECS) combines the advantages of laparoscopic internal view and operation with the precise localisation and removal capabilities of endoscopy. It's become a hot research topic in stomach-function-preserving surgery in recent years. Endoscopy provides a high-definition view of the mucosal surface from inside the cavity, allowing precise marking of tumour boundaries and submucosal dissection, while laparoscopy offers an external view of the serosal surface, enabling reliable full-thickness gastric wall resection, accurate suturing and regional lymph node inspection and management. Main LECS procedures include laparoscopic-assisted endoscopic full-thickness resection (LAEFR), endoscope-assisted wedge resection (EAWR), classic LECS and modified LECS. Several studies both domestic and international have shown LECS has advantages in treating various gastrointestinal tumours, but standardised procedures for early gastric cancer are not yet established, and current data is largely from retrospective studies, lacking high-quality prospective evidence.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: dongsheng wang Dr wang
- Telefonnummer: +86 18661807896
- E-Mail: wangdongsheng@qdu.edu.cn
Studienorte
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Shandong
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Qingdao, Shandong, China, 266000
- Anmeldung auf Einladung
- Qingdao University Affiliated Hospital West Coast Campus
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Qingdao, Shandong, China, 266011
- Rekrutierung
- Gastrointestinal Surgery at Qingdao University Affiliated Hospital
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Kontakt:
- wang dongsheng
- Telefonnummer: +86 18661807896
- E-Mail: wangdongsheng@qdu.edu.cn
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Gastroscopy biopsy confirmed a solitary gastric adenocarcinoma;
- White light endoscopy, magnifying endoscopy-image-enhanced endoscopy,(ME-IEE), endoscopic ultrasound and enhanced CT comprehensively assessed as cT1N0M0, with no distant metastasis;
- Assessed by MDT as unsuitable for simple ESD: including cases beyond the current guideline/consensus recommended ESD curative resection indications, or although at the endoscopic treatment border, significant fibrosis, scarring, non-lifting and other factors make complete endoscopic resection difficult and surgical function-preserving treatment has reasonable benefits;
- Lesion maximum diameter in principle ≤5 cm; for lesions close to 5 cm, near the cardia/pylorus or expected to cause stenosis or significant gastric deformation after local resection, they are listed as key review cases before surgery, and gastric preservation path can be directly abandoned during surgery;
- ECOG performance status score 0-1, able to tolerate general anaesthesia and laparoscopic surgery;
- Patient fully understands the potential benefits and uncertainties of SNNS/LECS, the possible false-negative risk of ICG single tracing and intraoperative pathology, as well as the possibility of conversion/additional standard radical gastrectomy, and has signed the informed consent form.
Exclusion Criteria:
- Preoperative imaging, endoscopy or MDT suggests cT2 or above, definite lymph node metastasis or distant metastasis;
- Pregnant or breastfeeding women;
- Previous major upper abdominal surgery leading to expected severe adhesions, significantly affecting SLB localisation or surgical implementation;
- Recurrent gastric cancer, multiple primary gastric cancers, or those who received preoperative radiotherapy and chemotherapy;
- Cases that have undergone ESD removal and achieved curative resection according to eCura standards;
- History of severe ICG allergy or deemed unsuitable by the researcher to use ICG;
- Patients with other untreated malignant tumours, severe cardiopulmonary dysfunction, or other conditions unable to tolerate general anaesthesia and pneumoperitoneum;
- Those unable to understand the study process or complete standard follow-up.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Perform a combined surgery using both microscopes
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Postoperative complications within 30 days after surgery
Zeitfenster: Within 30 days after surgery
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Within 30 days after surgery
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Overall survival (OS)
Zeitfenster: 1 year and 3 years after surgery
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1 year and 3 years after surgery
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disease-free survival (DFS)
Zeitfenster: 1 year and 3 years after surgery
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1 year and 3 years after surgery
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Local recurrence rate (LR)
Zeitfenster: 1 year and 3 years after surgery
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1 year and 3 years after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Sentinel lymph node prediction accuracy (sensitivity, specificity, etc.)
Zeitfenster: Up to two weeks after surgery (confirmed by paraffin pathology)
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Up to two weeks after surgery (confirmed by paraffin pathology)
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Sentinel lymph node tracing success rate
Zeitfenster: At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
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At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
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R0 resection rate
Zeitfenster: Up to two weeks after surgery(confirmed by paraffin pathology)
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Up to two weeks after surgery(confirmed by paraffin pathology)
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EORTC QLQ-C30/STO22 scale scores(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30)
Zeitfenster: Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery
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Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery
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Weight and Body Mass Index
Zeitfenster: Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
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Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
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Albumin and haemoglobin(g/L)
Zeitfenster: Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
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Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
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NRS2002 Nutrition Risk Screening
Zeitfenster: Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
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Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QYFYEC2026-37
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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