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

N/ANot Yet RecruitingNCT07546175

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine76 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

PGS

Interventions

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 electroacupunctureBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score

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.

Time frame: 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.