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Clinical Study of Electroacupuncture for Postoperative Gastroparesis in Patients With Digestive Tract Tumors
Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2026-04-14
Completion Date
2028-12-31
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
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
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.