Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
NCT Number: NCT06788548
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Preparation: The patient is positioned supine with general anesthesia. An orogastric tube and Foley catheter are inserted. Antibiotics are administered, and sequential stockings are applied. Port Placement: Pneumoperitoneum is created via a Veress needle at the umbilicus. Working ports are placed in the upper quadrants, with a fifth port for liver retraction. Abdominal Exploration: The abdomen is inspected for metastases, and peritoneal cytology is performed. Dissection and Lymph Node Removal: The lesser omentum is divided near the liver, reaching the cardia and diaphragm. The gastrocolic ligament is divided along the transverse colon. Lymph node dissection begins along the splenic artery, then proceeds to the left gastric artery and celiac nodes. The left gastric vessels are controlled with endoclips.After lymph node dissection, distal subtotal gastrectomy is performed. Digestive tract reconstruction is typically done through a mini-laparotomy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From the date of surgery to 30 days post-surgery
All-cause mortality occurring within 30 days after surgery.
Time frame: 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
Time frame: From the date of surgery to 30 days post-surgery
Rate of unscheduled reoperation within 30 days after the initial surgery
Time frame: From the date of surgery to 30 days post-surgery
Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery
Time frame: From the date of surgery to 7 days post-surgery
Time frame: At the time of surgery
Time frame: At the time of surgery
Time frame: 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.
Time frame: From the date of surgery to 30 days post-surgery
Proportion of patients requiring additional surgical procedures due to intraoperative or postoperative pathological findings
Time frame: At the time of surgery
Estimated total volume of blood loss during the surgical procedure
Time frame: 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
Time frame: 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
Time frame: From the time of admission to the time of discharge, assessed up to 3 weeks
Time frame: 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.
Time frame: 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.
Time frame: From 30 days prior to surgery to 5 years post-surgery
Time frame: From 30 days prior to surgery to 5 years post-surgery
Time frame: From 30 days prior to surgery to 5 years post-surgery
Time frame: From 30 days prior to surgery to 5 years post-surgery
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Beijing Friendship Hospital
Other
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
Acronym: FLECSS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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