Ear Acupuncture Preventing Delayed Gastric Emptying.

Last updated: October 7, 2019
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroparesis

Treatment

N/A

Clinical Study ID

NCT04118881
E2019158A
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Pancreatoduodenectomy is the preferred surgical method for periampullary diseases. The most common complication is gastric emptying disorder, which often greatly affects the quality of life of patients and prolongs the length of hospitalization. There are few reports on the treatment of gastric emptying disorder with single method, poor continuity of curative effect and low level of evidence. This study is to explore the clinical efficacy and safety of ear acupuncture in the prevention and treatment of DGE after pancreaticoduodenal surgery. This study is divided into two parts. The first part is to study the clinical efficacy and safety of auricular acupoint embedding in preventing gastric emptying disorder after pancreaticoduodenectomy. The second part is to study the clinical efficacy and safety of electroacupuncture in treating gastric emptying disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who underwent pancreaticoduodenectomy;

  • No delayed gastric emptying or gastrointestinal obstruction before operation.

  • ECOG score 0-2;

  • No opioid analgesia or gastrointestinal motility drugs were administered for more thanone week before operation.

  • Adequate blood cell counts were available during the screening period.

  • The blood biochemical indexes during screening period were as follows (48 hours beforeoperation to 14 days before operation): AST (SGOT), ALT (SGPT) were less than or equalto the upper limit of 2.5 times normal value (ULN). Total bilirubin is less than orequal to 300 micromol/L. ULN serum creatinine is within the normal limit, or the levelof serum creatinine is higher or lower than the normal value of institutions, but thecalculated clearance rate is greater than or equal to 60 mL/min/1.73 m2. If thecreatinine clearance rate is used, the actual body weight should be used to calculatethe creatinine clearance rate (e.g. using the Cockroft-Gault formula).

  • Coagulation function is normal.

  • Male or non-pregnant and non-lactating women who were older than or equal to 18 yearsold signed the informed consent. If a female patient is of childbearing age (regularmenstrual proof), the pregnancy test (such as serum beta-hCG) before the first studyof drug administration must be negative. If patients are sexually active, they mustagree to use contraceptive methods that researchers believe are adequate andappropriate during the study of drug administration. In addition, male and femalepatients must take contraceptive measures after treatment, as recommended by theproduct prescription information provided in the study manual.

  • The patient has been informed of the nature of the study and has agreed to participatein the study and signed an informed consent before participating in anyresearch-related activities.

  • Ability to comply with research visits and other programme requirements

Exclusion

Exclusion Criteria:

  • The patient did not receive standard pancreaticoduodenectomy.

  • Myocardial infarction, severe or unstable angina pectoris, coronary artery orperipheral artery bypass grafting, New York Heart Association (NYHA) grade III-IVheart failure, cerebrovascular accident, transient ischemic attack or epilepticseizure occurred within 30 days before operation.

  • Any condition that may impair patient safety or the integrity of research data,including serious medical risk factors, medical events, laboratory abnormalities orpsychiatric disorders;

  • The patient's access to any other clinical study or to a trial of an interventionaldrug may interfere with the evaluation of this study procedure.

  • Patients are unwilling or unable to follow the research procedure;

  • Researchers do not think it is suitable for inclusion.

  • Acupuncture and moxibustion is currently used or used in the past 30 days.

  • Ear trauma or unhealed ear wound

  • Stainless steel allergists

Study Design

Total Participants: 180
Study Start date:
October 10, 2019
Estimated Completion Date:
December 02, 2021

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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