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Not yet recruitingNCT07546175Updated Apr 22, 2026

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

An interventional study of Electroacupuncture and Sham electroacupuncture in PGS, sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • PGS
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In context

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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 (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Electroacupuncture group

    Behavioral: Electroacupuncture

  • Placebo comparator
    Sham electroacupuncture group

    Behavioral: Sham electroacupuncture

Interventions

  • BehavioralElectroacupuncture

    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

  • BehavioralSham 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.

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What researchers measure

Primary outcomes

  1. 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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07546175
Lead sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Responsible party
Kong Fanming (Professor, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine) — Principal investigator
First posted
Apr 22, 2026
Start date
Apr 14, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 22, 2026

Study contacts

Mengchao Wang, M.M
Contact
airk991@163.com
13292926115

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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