Phase
Condition
Gastroparesis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting
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