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临床试验/NCT06967571
NCT06967571招募中不适用

Reconstruction With a Lawrence-Hunt Jejunal Pouch for Upfront Total Gastrectomy - Study Protocol of a Prospective, Single-arm, Phase II Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS3 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
26
试验地点
3
主要终点
Dumping syndrome reduction rate

研究概览

简要总结

The aim of the study is to establish the efficacy of jejunal pouch reconstruction in reducing dumping syndrome in patients undergoing total gastrectomy, ultimately enhancing postoperative quality of life and nutritional status.

详细描述

Total gastrectomy (TG) with Roux-en-Y (RY) esophageal-jejunal anastomosis is performed for various gastric malignancies or as a prophylactic strategy in patients with hereditary diffuse gastric cancer syndrome harboring CDH1 mutation at risk of developing gastric cancer. The surgical procedure is, however, complicated in the post-operative months by weight loss and nutritional deficiency in most patients, requiring frequent follow-up, and by functional issues such as reflux and dumping syndrome in about 30% of cases, which significantly impact the patient's quality of life. To prevent the poorer outcomes reported by patients undergoing total gastrectomy, one strategy could be a modification of the reconstruction method using a jejunal pouch reconstruction (JP) that may mitigate symptoms by slowing gastric emptying and enhancing nutrient absorption. JP has so far proven several benefits in improving postoperative outcomes (reflux and dumping syndrome), nutritional outcomes, and QoL up to 2 years after surgery. The technique has been mostly studied in the Eastern countries (Japan and South Korea) and, since 2021, has been recommended by the French Association of Surgery as the technique of choice for reconstruction after total gastrectomy. However, in most European centers, this technique has not yet been introduced as a routine procedure due to a relative lack of data on the clinical benefit and risk profile in the Western population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-75 years.
  • Histologically confirmed gastric tumor (including adenocarcinoma, gastrointestinal stromal tumor - GIST- or neuroendocrine tumor) or patients with CDH1 mutation, scheduled for TG with a maximal esophageal resection of < 6 cm.
  • Informed consent capability.

排除标准

  • Prior abdominal surgeries affecting the jejunum.
  • Severe comorbidities or non-appropriate organ function: uncontrolled diabetes with HbA1C > 7.5, significant heart disease: New York Heart Association (NYHA) functional classification Class III or IV, chronic obstructive pulmonary disease (COPD) requiring oxygen supplementation or continuous positive airway pressure (CPAP), chronic corticosteroid therapy (daily for more than 6 months), neutrophil count < 2000/mm3, hemoglobin < 8.0 g/dL, platelet count < 100,000/mm3, serum total bilirubin > 1.5 mg/dL, serum aspartate aminotransferase (AST) >100 IU/L, serum alanine aminotransferase (ALT) >100 IU/L, and creatinine clearance (CCr) ≥ 50 mL/min), ECOG performance status >
  • Pregnancy or breastfeeding.

研究组 & 干预措施

Open or laparoscopic TG followed by JP reconstruction.

Experimental

All participants will undergo open or laparoscopic Total Gastrectomy (TG) followed by Jejunal Pouch (JP) reconstruction.

干预措施: Jejunal Pouch reconstruction. (Procedure)

结局指标

主要结局

Dumping syndrome reduction rate

时间窗: 12 months after surgery

Evaluate the reduction in the incidence of dumping syndrome after TG with JP reconstruction with the Sigstad questionnaire.

次要结局

  • Postoperative complications(12 months after surgery)
  • Nutritional status(3, 6 & 12 months after surgery)
  • Gastrointestinal Quality of Life Index (GIQLI)(3, 6 & 12 months after surgery)
  • Nutritional status - weight(3, 6 & 12 months after surgery)
  • Nutritional status - height(3, 6 & 12 months after surgery)
  • Nutritional status - Body Mass Index (BMI)(3, 6 & 12 months after surgery)
  • Dumping syndrome severity(The DSS was administered at 3, 6, and 12 months after surgery.)
  • Nutritional status - weight(3, 6 & 12 months after surgery)
  • Nutritional status - height(3, 6 & 12 months after surgery)
  • Nutritional status - Body Mass Index (BMI)(3, 6 & 12 months after surgery)
  • EORTC QLQ-C30(Assessments were performed at 3, 6, and 12 months after surgery)
  • Nutritional status(3, 6 & 12 months after surgery)
  • Gastrointestinal Quality of Life Index (GIQLI)(3, 6 & 12 months after surgery)
  • Postoperative complications(12 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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