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Not yet recruiting Not applicable NCT07546175

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

No applicable phase (e.g. observational)
Conditions: PGS

Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: 1. Aged 18-65 years; 2. History of digestive system tumor surgery; 3. Meet the diagnostic criteria for PGS (postoperative gastroparesis syndrome); 4. Voluntarily sign the informed consent form Exclusion Criteria: 1. Gastroparesis caused by other diseases, such as diabetes mellitus or scleroderma; 2. Use of medications that affect gastric smooth muscle function, such as morphine or atropine; 3. 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; 4. 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; 5. Women who are pregnant, breastfeeding, or planning to become pregnant.
Interventions
Electroacupuncture
BEHAVIORAL
Sham electroacupuncture
BEHAVIORAL
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
14.04.2026
Completion date
31.12.2028
Registry ID
NCT07546175
Source
clinicaltrials.gov
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