Acupuncture to speed stomach emptying after partial gastrectomy
Acupuncture for POstoperative Gastric Emptying dElay (APOGEE): A Multicenter Randomized Controlled Trial
This trial will test whether acupuncture helps people who have delayed stomach emptying after partial gastrectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07505927 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, single-blind, parallel-controlled trial enrolling 176 patients with delayed gastric emptying after partial gastrectomy. Participants are randomized 1:1 to receive either real acupuncture or sham acupuncture at participating hospitals in Shandong Province. The primary outcome is shortening the duration of delayed gastric emptying, and secondary outcomes include resolution of gastroparesis symptoms measured by the Gastroparesis Cardinal Symptom Index and monitoring of adverse events. All interventions and follow-up are conducted according to an approved protocol to evaluate both efficacy and safety.
Who should consider this trial
Good fit: Adults 18–80 years old who developed delayed gastric emptying after partial gastrectomy, confirmed by imaging or gastric emptying testing, and who do not have severe cardiac, hepatic, renal, or coagulation dysfunction are eligible.
Not a fit: Patients with serious postoperative complications (like anastomotic leakage, severe infection, gastrointestinal bleeding), mechanical obstruction, major organ failure, coagulation disorders, or known allergy to acupuncture are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, acupuncture could shorten recovery time and reduce symptoms such as nausea, bloating, and vomiting after partial gastrectomy.
How similar studies have performed: Some small randomized and pilot studies have suggested acupuncture can improve gastric motility and symptoms, but high-quality multicenter randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-80 years, regardless of sex. 2. Patients who have undergone partial gastrectomy. 3. Patients presenting with postoperative gastroparesis symptoms, confirmed by imaging or gastric emptying scintigraphy, and clinically diagnosed with gastroparesis. 4. No severe cardiac, hepatic, renal, or coagulation dysfunction. 5. No participation in other interventional clinical trials within the past month. 6. Able to provide written informed consent and comply with the treatment and follow-up procedures. Exclusion Criteria: 1. Patients with severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or coagulation disorders. 2. Patients who develop serious postoperative complications after partial gastrectomy, such as anastomotic leakage, gastrointestinal bleeding, or severe infections, or conditions that may affect the assessment of gastric motility, such as ascites or intestinal obstruction. 3. Patients with a known allergy to acupuncture or with skin damage, infection, or severe scarring at the needle insertion sites that would prevent proper acupoint selection or needling. 4. Patients with diagnosed psychiatric disorders, cognitive impairment, or those unable to cooperate with treatment procedures, symptom assessment, or follow-up. 5. Patients who have used medications that may significantly affect gastric motility within the past week and cannot discontinue their use. 6. Pregnant or breastfeeding women, or individuals with other special physiological conditions that may make them unsuitable for participation in acupuncture research.
Where this trial is running
Jinan, Shandong
- Qilu hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: zhibo Yan, PhD
- Email: 201362006567@sdu.edu.cn
- Phone: 86＋18560085166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.