Clinical Study of Electroacupuncture for Postoperative Gastroparesis in Patients With Digestive Tract Tumors

Обзор

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.

Вмешательства

• Поведенческое Electroacupuncture
  Electroacupuncture was applied to Zusanli,Shangjuxu， Tianshu, and Zhongwan. Needles were inserted perpendicularly into the skin to a depth of 20-40 mm. After achieving deqi (needling sensation) locally, the bilateral Zusanli and Shangjuxu points were connected to an electroacupuncture device. Continuous wave was used, with a frequency of 10 Hz and an intensity of 3 mA
• Поведенческое Sham electroacupuncture
  Sham points corresponding to Zusanli, Shangjuxu， Tianshu, and Zhongwan were selected. Needles were inserted to a depth of approximately 10-15 mm without any manipulative techniques. Electrode connection and device settings were identical to those in the electroacupuncture group, but without skin penetration, electrical output, or needling manipulation to facilitate deqi.

Первичные конечные точки

• Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07546175 · TYLL2025[K]122

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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