PGSNCT07546175
Clinical Study of Electroacupuncture for Postoperative Gastroparesis in Patients With Digestive Tract Tumors
A study testing Electroacupuncture in people with PGS, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PGS
- What is being tested?
- Electroacupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- PGS
- Being tested
- Electroacupuncture, Sham electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureBehavioural
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 electroacupunctureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | Not described Receives: Behavioral: Electroacupuncture |
| Sham electroacupuncture group | Placebo comparator | Not described Receives: Behavioral: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start14 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PGSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kong Fanming, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546175
- Sponsor's protocol ID
- TYLL2025[K]122
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Electroacupuncture for Postoperative Gastroparesis in Patients With Digestive Tract Tumors
- ClinicalTrials.gov ID
- NCT07546175
- Acronym / sponsor ID
- TYLL2025[K]122
- Conditions
- PGS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Behavioral: Electroacupuncture |
| Sham electroacupuncture group | Placebo comparator | Behavioral: Sham electroacupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture 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 | Behavioural | Electroacupuncture group |
| Sham electroacupunctureSham 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. | Behavioural | Sham electroacupuncture group |
Primary outcome
Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Related trials for PGS
RecruitingObservational study
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Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with PGS, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengchao Wang, M.M (13292926115, airk991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Diary of Gastroparesis Cardinal Symptom Index (GCSI-DD) score (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.