Clinical Study of Electroacupuncture for Postoperative Gastroparesis in Patients With Digestive Tract Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score
研究概览
简要总结
This study aims to design and conduct a prospective, multicenter, randomized, parallel-controlled, sham-controlled clinical trial to evaluate the clinical efficacy of electroacupuncture for postsurgical gastroparesis syndrome (PGS) after digestive tract tumor surgery and systematically assess its clinical safety. By measuring gastrointestinal hormones, inflammatory factors, proteomics and metabolomics, we intend to explore the mechanism underlying the improvement of postoperative gastrointestinal motility by electroacupuncture. We will identify the optimal population for electroacupuncture in PGS by analyzing baseline characteristics and efficacy correlations, to provide evidence for individualized clinical intervention. The primary endpoint is the Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score at Day 14 of treatment. Finally, based on clinical data, this study will define the eligible population and optimal protocol of electroacupuncture for PGS, and further standardize and promote its clinical application in postoperative complications of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years;
- •History of digestive system tumor surgery;
- •Meet the diagnostic criteria for PGS (postoperative gastroparesis syndrome);
- •Voluntarily sign the informed consent form
排除标准
- •Gastroparesis caused by other diseases, such as diabetes mellitus or scleroderma;
- •Use of medications that affect gastric smooth muscle function, such as morphine or atropine;
- •Suspected or confirmed history of alcohol addiction or drug abuse, or concomitant cognitive impairment or severe mental illness that precludes cooperation with the clinical study;
- •Severe organic diseases of vital organs, such as severe chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary fibrosis, or complicated by respiratory failure; renal insufficiency or glomerulosclerosis; or severe disturbances of fluid, electrolyte, or acid-base balance;
- •Women who are pregnant, breastfeeding, or planning to become pregnant.
研究组 & 干预措施
Electroacupuncture group
干预措施: Electroacupuncture (Behavioral)
Sham electroacupuncture group
干预措施: Sham electroacupuncture (Behavioral)
结局指标
主要结局
Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score
时间窗: Assessment time points include before treatment, on day 7 and day 14 of treatment, as well as follow-ups on days 7, 14, 21, and 28 after treatment.
The GCSI-DD is a daily assessment tool used to evaluate the severity of core gastroparesis symptoms, including nausea, vomiting, abdominal bloating, early satiety, and postprandial fullness. It serves as a key indicator for determining the efficacy of electroacupuncture in alleviating postsurgical gastroparesis syndrome. Assessment time points include before treatment, on day 7 and day 14 of treatment, as well as follow-ups on days 7, 14, 21, and 28 after treatment.
次要结局
未报告次要终点
研究者
Kong Fanming
Professor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine