A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

Официальное название

A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique

Обзор

This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III). The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.

Вмешательства

• Процедура Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
  Surgical Operation: 1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. 2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. 3. Anastomosis Method: esophagogastrostomy by fissure technique. 4. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that

Первичные конечные точки

• Assess intraoperative Perioperative Safety by Duration of surgery. [Срок оценки: intraoperative]
• Assess intraoperative Perioperative Safety by Duration of anastomosis. [Срок оценки: intraoperative]
• Assess intraoperative Perioperative Safety by blood loss . [Срок оценки: intraoperative]
• Postoperative recovery course [Срок оценки: 30 days after the surgery]
• Postoperative TNM staging by Pathological findings . [Срок оценки: 30 days after the surgery]

Вторичные конечные точки (4)

• The incidence of postoperative reflux esophagitis [Срок оценки: 3 months after surgery]
• The incidence of postoperative anastomotic stenosis [Срок оценки: 3 months after surgery]
• Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30 [Срок оценки: 3 months after surgery]
• Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale [Срок оценки: 3 months after surgery]

Критерии участия

Критерии включения

• Age between 18 and 75 years old;
• Pathologically confirmed as adenocarcinoma;
• Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
• If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
• For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
• Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
• No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
• No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
• Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
• Preoperative ASA (American Society of Anesthesiologists) score I-III.
• Good function of important organs.
• Signed informed consent.

Критерии исключения

• Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
• Pregnant or lactating women;
• Patients with severe mental illness;
• Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
• Severe respiratory diseases, with FEV1 < 50% of predicted value;
• History of other malignant tumors in the past 5 years;
• Severe liver or kidney dysfunction;
• Unstable angina or myocardial infarction within the last 6 months;
• History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
• Systemic use of glucocorticoids within the last 1 month;
• Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
• Patient has participated in or is currently participating in other clinical trials (within the last 6 months).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06300879 · 2023-1058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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