Clinical trial NCT06788548: Combined Endoscopic-laparoscopic Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer
Official title: Combined Endoscopic-laparoscopic Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer: a Multicenter Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Gastric Cancer
Keywords: Early Gastric Cancer
Sentinel Lymph Node
Basin Dissection
Laparoscopic surgery
Safety AND Efficacy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. Combined endoscopic-laparoscopic sentinel node navigation surgery seems to be the promising solution according to previous study, however evidence-based medicine in China was lacking. It is imperative to establish its safety and efficacy in Chinese patients with EGC.


Eligibility criteria: Inclusion Criteria:

* 1) Patients aged 18-80 years, regardless of gender. 2) Patients with Eastern Cooperative Oncology Group (ECOG) score ≤ 2 and American Society of Anesthesiologists (ASA) score ≤ 2 who are candidates for a curative D2 gastrectomy.

  3) Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.

  4) Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT\>109 /L).

  5) Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.

  7) Patients with cT1NxM0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition.

Exclusion Criteria:

* 1) Patients with a contraindication for gastroscopy. 2) Patients with uncontrollable diseases, such as coagulation disorders, epilepsy, central nervous system diseases or mental disorders, cardiopulmonary insufficiency, unstable angina, myocardial infarction, a cerebrovascular accident that occurred within 6 months, and other surgical contraindications.

  3) Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.

  4) Patients with gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdominopelvic cavity, or a history of other malignant tumors within the previous 5 years.

  5) Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use.

  8) Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.

Primary outcomes:
measure: 5-year overall recurrence rate.
timeFrame: From treatment to 5-years after surgery
Secondary outcomes:
measure: 5-year overall survival
timeFrame: From treatment to 5-years after surgery
measure: Mortality (within 30 days after surgery)；Unscheduled second surgery (within 30 days after surgery) and Unplanned return to hospital (within 30 days after surgery)
timeFrame: From treatment to 30-days after surgery
measure: rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine；Rates of remedial and additional surgery
timeFrame: From enrollment to 1 week after surgery
measure: Perioperative complication rate (within 30 days after surgery, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula
timeFrame: From treatment to 30-days after surgery
measure: Operation time
timeFrame: From treatment to 1 week after surgery
measure: R0 resection rate
timeFrame: From treatment to 1 week after surgery
measure: additional surgical operation rate
timeFrame: From treatment to 5-years after surgery
measure: blood loss
timeFrame: From treatment to 30-days after surgery
measure: postoperative length of stay
timeFrame: From treatment to 30-days after surgery
measure: overall hospitalization cost
timeFrame: From treatment to 5-years after surgery
measure: Gastric emptying scintigraphy result
timeFrame: From treatment to 5-years after surgery
measure: date of gas evacuation
timeFrame: From treatment to 30-days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References: