Acupuncture for Postoperative Gastric Emptying Delay

NCT07505927 | Recruiting DMC

• 1 other identifier: Wenbinyu2026Acupuncture
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter clinical trial, conducted at Qilu Hospital of Shandong University and collaborating institutions, prospectively assesses the efficacy and safety of acupuncture for postoperative delayed gastric emptying. Eligible participants will be prospectively enrolled and randomized into different groups per the study protocol. The primary endpoint is the reduction in the duration of delayed gastric emptying, while secondary endpoints include the complete resolution of cardinal gastroparetic symptoms, such as abdominal distension, nausea, and vomiting. All study procedures adhere to the ethical standards outlined in the approved protocol.

Conditions

Gastroparesis Postoperative; Delayed Gastric Emptying Following Procedure

Keywords

Gastroparesis; Acupuncture; Delayed Gastric Emptying; partial gastrectomy

Outcome Measures

Primary Outcomes (1)

• Time to Recovery from Postoperative Gastroparesis

  Time from first diagnosis of postoperative gastroparesis to recovery of gastroparesis, defined as resolution of symptoms (e.g., nausea, vomiting, abdominal distension), tolerance of oral intake, and removal of gastric decompression without recurrence

  From date of first diagnosis of postoperative gastroparesis through hospital discharge, assessed up to 12 months

Secondary Outcomes (14)

• Change in Gastroparesis Cardinal Symptom Index score

  Baseline, Day 7, Day 14, 1, 3, 6, and 12 months

• Daily Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Score

  From enrollment to the resolution of gastroparesis up to 12 months

• Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30（EORTC QLQ-C30 ）Score

  Baseline, Day 7, Day 14, 1, 3, 6, and 12 months

• Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module （EORTC QLQ-STO22 ）Score

  Baseline, Day 7, Day 14, 1, 3, 6, and 12 months

• Gastric Emptying Rate

  From enrollment to the to the resolution of gastroparesis up to 12 months

Study Arms (2)

Acupuncture Group

EXPERIMENTAL

Acupuncture Group: Patients received acupuncture therapy in addition to the same standardized care regimen as provided to the control group.

Procedure: Acupuncture

Control Group

SHAM COMPARATOR

Control Group: Participants received standard care for postoperative gastroparesis, including dietary modification, gastrointestinal decompression, enteral nutritional support, and prokinetic agents, in combination with sham acupuncture.

Procedure: sham acupuncture

Interventions

Acupuncture PROCEDURE

Intervention Description: Participants receive traditional Chinese medicine acupuncture administered using sterile filiform needles at acupoints selected based on clinical presentation. The treatment session duration and frequency are identical to those in the control group. All participants continue to receive standard postoperative care.

Also known as: Traditional Chinese Medicine Acupuncture

Acupuncture Group

sham acupuncture PROCEDURE

Participants receive sham acupuncture administered using identical filiform needles as the experimental group, with superficial insertion at non-acupoints and without needle manipulation. The treatment session duration and frequency are identical to those in the experimental group. All participants continue to receive standard postoperative care.

Also known as: Placebo Acupuncture

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years, regardless of sex.
• Patients who have undergone partial gastrectomy.
• Patients presenting with postoperative gastroparesis symptoms, confirmed by imaging or gastric emptying scintigraphy, and clinically diagnosed with gastroparesis.
• No severe cardiac, hepatic, renal, or coagulation dysfunction.
• No participation in other interventional clinical trials within the past month.
• Able to provide written informed consent and comply with the treatment and follow-up procedures.

You may not qualify if:

• Patients with severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or coagulation disorders.
• 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.
• 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.
• Patients with diagnosed psychiatric disorders, cognitive impairment, or those unable to cooperate with treatment procedures, symptom assessment, or follow-up.
• Patients who have used medications that may significantly affect gastric motility within the past week and cannot discontinue their use.
• Pregnant or breastfeeding women, or individuals with other special physiological conditions that may make them unsuitable for participation in acupuncture research.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Weifang Yidu Central Hospital: collaborator
• The People's Hospital of Yinan County: collaborator

Study Sites (1)

Qilu hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

zhibo Yan, PhD

CONTACT

86＋18560085166; 201362006567@sdu.edu.cn

wenbin Yu, PhD

CONTACT

86＋18560085155; wenbin_yu2003@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. 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.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available 6 months after the publication of the primary study results, for a period of 5 years.
• Access Criteria: Access will be granted to researchers who submit a methodologically sound research proposal and sign a data use agreement.

Locations

CN (1)