Description

This prospective, randomized, controlled, multicenter trial, conducted collaboratively by Qilu Hospital of Shandong University and its partner institutions, evaluates the efficacy and safety of acupuncture for the treatment of postoperative delayed gastric emptying (DGE).

objectives：

Primary objectives:

1. To assess the clinical efficacy of acupuncture in patients with gastroparesis after partial gastrectomy, specifically in terms of promoting the recovery of gastric motility, accelerating gastric emptying, and alleviating symptoms as measured by the Gastroparesis Cardinal Symptom Index (GCSI).
2. To provide robust evidence-based medical evidence for the use of acupuncture in managing postoperative gastroparesis.
3. The objective of this study is to evaluate the efficacy and safety of acupuncture for gastroparesis following partial gastrectomy in a randomized controlled trial.

Secondary objective:

To evaluate the safety of acupuncture by monitoring the incidence of adverse events associated with the treatment.

Study Design This study is a multicenter, randomized, single-blind, parallel-controlled clinical trial. The trial will be conducted at Qilu Hospital of Shandong University, Weifang Yidu Central Hospital, and Yinan County People's Hospital. A total of 176 patients who develop gastroparesis following partial gastrectomy will be recruited.

Participants will be randomly assigned in a 1:1 ratio to either the Sham Acupuncture group or the Normal Acupuncture group.

The randomization sequence will be generated by the Quality Control Committee using a computer-based random number generator.

During the treatment period, clinical data, intraoperative information, perioperative status, and postoperative outcomes related to gastroparesis will be collected from both groups. Gastric fluid and blood samples will also be obtained for relevant laboratory analyses. In addition, patients will be followed up to evaluate the clinical efficacy of acupuncture for gastroparesis after gastric surgery.

Clinical data, including intraoperative findings and perioperative parameters, were systematically collected for all participants. Postoperative outcomes following acupuncture intervention were documented. Blood samples were obtained for laboratory analyses. All patients were followed up to demonstrate the clinical efficacy of acupuncture in patients with postoperative gastric paralysis

Intervention Measures

Licensed acupuncturists underwent standardized training in acupoint localization and needling techniques to ensure procedural uniformity. Participants received standard clinical management-including dietary modifications, gastrointestinal decompression, enteral nutrition, and prokinetic agents-and were subsequently randomized into two study arms:

Acupuncture Group (AG): Received active acupuncture in conjunction with standard care.

Sham Acupuncture Group (SAG): Received standard care combined with non-penetrating sham acupuncture. Blunt-tipped sterile needles were employed to replicate the appearance of conventional acupuncture needles without penetrating the skin, thereby maintaining participant blinding. Adhesive pads were applied at all needle sites in both groups to conceal insertion points and preserve visual masking.

Gastric motility and symptom improvement were assessed at the conclusion of the intervention. The use of any additional medications targeting gastroparesis outside the standard protocol was prohibited, and all concomitant pharmacological interventions were meticulously recorded.

Study Endpoints Primary Endpoint The primary outcome is the time from first diagnosis of postoperative gastroparesis to the resolution of gastroparesis. Resolution is defined as the first time point at which all of the following criteria are met: no requirement for nasogastric decompression; disappearance of core symptoms of gastroparesis, including abdominal distension, nausea, and vomiting; ability to tolerate a liquid or semi-liquid diet without recurrence of vomiting or abdominal distension; no need for enteral or parenteral nutritional support; restoration of normal bowel sounds; and passage of flatus or stool.

Secondary Endpoints

1. Gastric emptying rate：Gastric emptying rate will be assessed using radionuclide gastric emptying scintigraphy with a standardized solid test meal at baseline, at two weeks during treatment, and at the end of the treatment period. The main parameters include the percentage of gastric retention at 2 and 4 hours after the meal, as well as the gastric emptying half-time.
2. Radiological evolution of abdominal findings: Standing and supine abdominal radiographs will be obtained at baseline, at two weeks during treatment, and at the end of the treatment period to evaluate changes in gastric retention and intestinal gas patterns.
3. Gastroparesis Cardinal Symptom Index (GCSI) Score：The Gastroparesis Cardinal Symptom Index (GCSI), which consists of nine items across three symptom domains (nausea/vomiting, postprandial fullness/early satiety, and bloating), will be used to evaluate symptom severity. Each item is rated on a 6-point Likert scale ranging from 0 (no symptoms) to 5 (very severe symptoms). The total score is calculated as the mean of the three subscale scores, with higher scores indicating more severe symptoms. Assessments will be performed at baseline, weekly during the intervention period, and during the follow-up phase.
4. Daily Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Score:

The Daily Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to assess daily symptom severity. The total score ranges from 0 to 4, with higher scores indicating more severe symptoms.Assessments will be recorded daily from enrollment until the resolution of gastroparesis and will continue to be monitored throughout the follow-up period, up to 12 months. 5. Nutritional status assessment: Nutritional Status Assessment:Nutritional status will be evaluated using both anthropometric and biochemical indicators. Body weight and serum albumin levels will be measured at baseline, at 14 days during the intervention, at the end of the treatment period, and at the 12-month follow-up, and changes across these time points will be compared. 6. Length of hospital stay：Length of hospital stay (LOS) is defined as the number of days from the date of partial gastrectomy to hospital discharge. Discharge will be considered when the following criteria are met: recovery of gastrointestinal function (tolerance of solid or semi-liquid food without significant vomiting); stable organ function with independent mobility; satisfactory wound healing without signs of infection or other postoperative complications; and agreement of the participant with the discharge plan. 7. Blinding assessment：To ensure internal validity and minimize potential bias, the effectiveness of participant blinding will be evaluated. Within 30 minutes after both the first and the final treatment sessions, participants will be asked to complete a questionnaire indicating which group they believe they were assigned to (acupuncture group or sham acupuncture group). 8. Credibility and expectancy：After the first treatment session, participants' perceptions of treatment credibility and their expectations regarding therapeutic effects will be assessed using the Credibility Expectancy Questionnaire (CEQ). 9. Adverse events related to acupuncture：Any unexpected physical signs, symptoms, or pathological conditions occurring during the acupuncture intervention will be recorded as adverse events (AEs), regardless of whether a causal relationship with the treatment is confirmed. Investigators will carefully document each event in the case report forms (CRFs), including its occurrence, severity, duration, and outcome. 10. Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30（EORTC QLQ-C30 ）Score. 11. Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module （EORTC QLQ-STO22 ）Score。 12. Electrogastrogram (EGG)
13. Daily Gastric Drainage Volume
14. Gastric juice characteristics (color and presence of sediment) assessed by visual inspection. Color is categorized as clear, yellowish, greenish, coffee-ground, or bloody. Sediment is recorded as present or absent. 15. C-reactive Protein (CRP) Level and Interleukin Levels 16. Gastrointestinal Hormone Levels

Follow-up Schedule

Efficacy and safety assessments were performed at the following time points:

Baseline: Prior to treatment initiation On-treatment: At 1 week and At 2 weeks after treatment commencement End of treatment: the resolution of gastroparesis Long-term follow-up: At 1 month, 3 months, 6 months, and 12 months post-treatment

Adverse Event Monitoring Safety monitoring was conducted throughout the study period. The principal investigator was responsible for the ongoing surveillance and documentation of all adverse events .

Monitoring Procedures:

Vital signs and other safety parameters were assessed at each scheduled visit. All adverse events, regardless of severity or perceived relationship to treatment, were recorded and followed until resolution or stabilization.

Management of Adverse Events:

Participants experiencing mild adverse reactions-such as needling site pain, vasovagal syncope, or local infection-received appropriate symptomatic treatment. The principal investigator determined, based on clinical judgment, whether study intervention should be continued, temporarily suspended, or permanently discontinued.

In the event of a serious adverse event , study intervention was immediately discontinued, and the participant received necessary medical care. The SAE was reported to the institutional review board (IRB) and relevant regulatory authorities within 24 hours, in accordance with applicable guidelines.

All data will be analyzed using appropriate methods in accordance with the statistical plan.

This trial was performed in strict compliance with the ethical guidelines of the Declaration of Helsinki and the Good Clinical Practice (GCP) principles. The study protocol was approved by the Institutional Review Board (IRB) of each participating center prior to initiation. Written informed consent was obtained from all participants before enrollment. Throughout the study, rigorous measures were implemented to safeguard the authenticity, completeness, and reliability of all collected data.