Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Early postoperative complications
研究概览
简要总结
Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established.
Hand-sewn anastomosis relies on advanced endoscopic suturing skills, making it technically demanding and only performed in a limited number of hospitals.
Linear anastomosis is simple to perform and the most widely used in clinical practice. However, it requires resection of a longer segment of the distal esophagus and may struggle to ensure adequate margins for high-positioned tumors or unclear resection boundaries.
Circular anastomosis is a classic method. Its end-to-side approach preserves more esophageal length, making it suitable for high-positioned tumors without the need to close a common opening. Various techniques (e.g., the reverse-puncture method and the Orvil™ transoral anvil technique) have been reported. However, due to challenges such as purse-string suturing, complex anvil placement, and restricted stapler maneuverability, widespread adoption remains difficult.
Prof. Du Jianjun's team innovatively employed endoscopic purse-string forceps and a multifunctional sealing ring to achieve circular anastomosis, demonstrating preliminary technical advantages. This study further explores its feasibility and short-term outcomes in totally endoscopic total gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, regardless of gender; Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ cancer, only Siewert type III and type II (without requiring thoracotomy) are eligible (applicable to multiple primary cancers); Preoperative assessment by a gastrointestinal surgeon and imaging specialist confirming cStage I-III disease with eligibility for curative-intent R0 resection. Patient consents to surgery and is deemed surgically fit by the surgeon; Anticipated R0 resection achievable via total gastrectomy with D1+/D2 lymphadenectomy; Expected survival ≥6 months; ECOG Performance Status (PS) score (see Appendix 2) of 0 or 1; Adequate major organ function; Body weight ≥40 kg or BMI >18.5 and <30 kg/m²; No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy; Patient has read and fully understood the informed consent form and voluntarily signed it
排除标准
- •History of other active malignancies within the past 5 years or concurrent malignancies (except cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate/cervix/breast, Stage I lung/colorectal cancer, etc.).
- •Previous upper abdominal surgery (excluding laparoscopic cholecystectomy). History of gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
- •Requirement for concurrent surgery for other diseases. Emergency surgery due to gastric cancer complications (bleeding, obstruction, or perforation).
- •Planned or prior organ/bone marrow transplantation. Blood transfusion within 2 weeks before surgery, bleeding history, or Grade ≥3 hemorrhage (CTCAE v4.0) within 4 weeks.
- •Coagulopathy (INR >1.5 without anticoagulants) or use of anticoagulants (warfarin/heparin). Prophylactic low-dose warfarin (≤1 mg/day) or aspirin (≤100 mg/day) is permitted if INR ≤1.
- •Arterial/venous thrombosis within 6 months (e.g., stroke, DVT, pulmonary embolism), excluding catheter-related thrombosis from prior chemotherapy.
- •Myocardial infarction within 6 months or uncontrolled arrhythmia (QTc ≥450 ms [men]/≥470 ms [women] by Fridericia's formula).
- •NYHA Class III-IV heart failure or LVEF <50%. Ventilatory dysfunction (FEV1 <50% predicted). Urinary protein ≥++ or 24-hour urine protein >1.0 g. Clinically significant pleural/peritoneal effusion requiring intervention. HIV infection. Active tuberculosis. Non-healing wounds or incomplete fracture healing. Active/suspected autoimmune disease (stable cases without immunosuppressants allowed).
- •Severe autoimmune diseases (e.g., SLE, IBD), chronic diarrhea disorders, or active HBV/HCV (HBV DNA <500 copies/mL permitted).
- •Systemic corticosteroids (>10 mg/day prednisone equivalent) within 14 days (topical/inhaled steroids or physiologic replacement doses allowed).
- •Active infection requiring systemic antibiotics within 14 days (prophylactic antibiotics permitted).
- •Live vaccines within 28 days (inactivated flu vaccines allowed). Concurrent participation in another surgical trial. Alcohol/drug abuse history (abstinent patients eligible). Non-compliance or incomplete data affecting safety/efficacy assessments. Pregnancy/lactation. Other conditions deemed high-risk by investigators. Investigator-determined ineligibility.
研究组 & 干预措施
Laparoscopic Roux-en-Y esophagojejunostomy using purse-string forceps and sealing ring
Performing totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring.
干预措施: Laparoscopic purse-string forceps and multifunctional sealing ring (Procedure)
结局指标
主要结局
Early postoperative complications
时间窗: 30 days
Early postoperative complications were defined as adverse events occurring within 30 days after surgery. All complications were classified according to the Clavien-Dindo grading system and recorded numerically.
次要结局
- Postoperative recovery situation(30 days)
- Late postoperative complications(2 years)
研究者
Li Yang
Prof.
The First Affiliated Hospital with Nanjing Medical University