Acupuncture for POstoperative Gastric Emptying dElay (APOGEE): A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Time to Recovery from Postoperative Gastroparesis
研究概览
简要总结
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.
详细描述
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:
- 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).
- To provide robust evidence-based medical evidence for the use of acupuncture in managing postoperative gastroparesis.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acupuncture Group
Acupuncture Group: Patients received acupuncture therapy in addition to the same standardized care regimen as provided to the control group.
干预措施: Acupuncture (Procedure)
Control Group
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.
干预措施: sham acupuncture (Procedure)
结局指标
主要结局
Time to Recovery from Postoperative Gastroparesis
时间窗: From date of first diagnosis of postoperative gastroparesis through hospital discharge, assessed up to 12 months
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
次要结局
- 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)
- Upper Gastrointestinal Radiography Findings(From enrollment to the to the resolution of gastroparesis up to 12 months)
- Electrogastrogram (EGG)(From enrollment to the to the resolution of gastroparesis up to 12 months)
- Daily Gastric Drainage Volume(From enrollment to the to the resolution of gastroparesis up to 12 months)
- Gastric Juice Characteristics(From enrollment to the to the resolution of gastroparesis up to 12 months)
- C-reactive Protein (CRP) Level(Baseline, Day 7, Day 14, and 1, 3, 6 ,12 months after enrollment.)
- Interleukin Levels(Baseline, Day 7, Day 14, and 1, 3, 6 ,12 months after enrollment.)
- Gastrointestinal Hormone Levels(Baseline, Day 7, Day 14, and 1, 3, 6 ,12 months after enrollment.)
- Serum Albumin Level(Baseline, Day 7, Day 14, and 1, 3, 6 ,12 months after enrollment.)
- Body Weight(From enrollment to the to the resolution of gastroparesis up to 12 months)