Ear Acupuncture Preventing Delayed Gastric Emptying.
Primary Purpose
Auricular Acupoint Embedding, Pancreaticoduodenectomy, Delayed Gastric Emptying
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ear Acupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Auricular Acupoint Embedding
Eligibility Criteria
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 than one 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 before operation to 14 days before operation): AST (SGOT), ALT (SGPT) were less than or equal to the upper limit of 2.5 times normal value (ULN). Total bilirubin is less than or equal to 300 micromol/L. ULN serum creatinine is within the normal limit, or the level of serum creatinine is higher or lower than the normal value of institutions, but the calculated clearance rate is greater than or equal to 60 mL/min/1.73 m2. If the creatinine clearance rate is used, the actual body weight should be used to calculate the 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 years old signed the informed consent. If a female patient is of childbearing age (regular menstrual proof), the pregnancy test (such as serum beta-hCG) before the first study of drug administration must be negative. If patients are sexually active, they must agree to use contraceptive methods that researchers believe are adequate and appropriate during the study of drug administration. In addition, male and female patients must take contraceptive measures after treatment, as recommended by the product prescription information provided in the study manual.
- The patient has been informed of the nature of the study and has agreed to participate in the study and signed an informed consent before participating in any research-related activities.
- Ability to comply with research visits and other programme requirements
Exclusion Criteria:
- The patient did not receive standard pancreaticoduodenectomy.
- Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass grafting, New York Heart Association (NYHA) grade III-IV heart failure, cerebrovascular accident, transient ischemic attack or epileptic seizure 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 or psychiatric disorders;
- The patient's access to any other clinical study or to a trial of an interventional drug 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
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
treatment group
control group
Arm Description
The treatment group was given intradermal needling at ear acupoints: cardia (CO3), stomach (CO4), sympathetic (HX4)
The control group was given intradermal needling at ear acupoints: spiral area (HX7 and HX8).
Outcomes
Primary Outcome Measures
Grading of delayed gastric emptying
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Grading of delayed gastric emptying
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Grading of delayed gastric emptying
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Grading of delayed gastric emptying
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Secondary Outcome Measures
Changes of motilin before and after operation
Serum motilin was measured at Day0 and Day7 after operation.
Changes of somatostatin before and after operation
Somatostatin were measured at Day0 and Day7 after operation.
Full Information
NCT ID
NCT04118881
First Posted
September 26, 2019
Last Updated
October 7, 2019
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04118881
Brief Title
Ear Acupuncture Preventing Delayed Gastric Emptying.
Official Title
Preoperative Ear Acupuncture to Prevent Delayed Gastric Emptying After Pancreatoduodenectomy.A Single-center Prospective Randomized Controlled Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Anticipated)
Primary Completion Date
August 2, 2021 (Anticipated)
Study Completion Date
December 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auricular Acupoint Embedding, Pancreaticoduodenectomy, Delayed Gastric Emptying
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
The treatment group was given intradermal needling at ear acupoints: cardia (CO3), stomach (CO4), sympathetic (HX4)
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
The control group was given intradermal needling at ear acupoints: spiral area (HX7 and HX8).
Intervention Type
Other
Intervention Name(s)
Ear Acupuncture
Intervention Description
Auricular Acupuncture (AA) is a micro-system of acupuncture and moxibustion initiated by Chinese and French doctors. All acupoints are distributed in the ear. In the treatment of perioperative patients, ear needle is far away from the surgical wound and its minimally invasive and tolerable position has obvious advantages over body needle.AA can regulate the function of corresponding organs at acupoints. The theoretical basis of TCM is holistic concept and syndrome differentiation and treatment.AA can prevent and treat perioperative nausea and vomiting. A number of randomized controlled trials and retrospective studies have confirmed that AA has obvious advantages in preventing nausea and vomiting in perioperative period compared with routine prevention, and its possible mechanism is ear-directed stimulation of the ear branch of vagus nerve, thereby enhancing gastrointestinal motility and accelerating gastric emptying.
Primary Outcome Measure Information:
Title
Grading of delayed gastric emptying
Description
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Time Frame
Day3 after operation
Title
Grading of delayed gastric emptying
Description
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Time Frame
Day5 after operation
Title
Grading of delayed gastric emptying
Description
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Time Frame
Day7 after operation
Title
Grading of delayed gastric emptying
Description
The assessment was conducted in accordance with the DGE guidelines for post-PD surgery issued by the International Research Group of Pancreatic Surgery (ISGPS) in 2007.
Time Frame
Day14 after operation
Secondary Outcome Measure Information:
Title
Changes of motilin before and after operation
Description
Serum motilin was measured at Day0 and Day7 after operation.
Time Frame
Day0 and Day7 after operation.
Title
Changes of somatostatin before and after operation
Description
Somatostatin were measured at Day0 and Day7 after operation.
Time Frame
Day0 and Day7 after operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 than one 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 before operation to 14 days before operation): AST (SGOT), ALT (SGPT) were less than or equal to the upper limit of 2.5 times normal value (ULN). Total bilirubin is less than or equal to 300 micromol/L. ULN serum creatinine is within the normal limit, or the level of serum creatinine is higher or lower than the normal value of institutions, but the calculated clearance rate is greater than or equal to 60 mL/min/1.73 m2. If the creatinine clearance rate is used, the actual body weight should be used to calculate the 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 years old signed the informed consent. If a female patient is of childbearing age (regular menstrual proof), the pregnancy test (such as serum beta-hCG) before the first study of drug administration must be negative. If patients are sexually active, they must agree to use contraceptive methods that researchers believe are adequate and appropriate during the study of drug administration. In addition, male and female patients must take contraceptive measures after treatment, as recommended by the product prescription information provided in the study manual.
The patient has been informed of the nature of the study and has agreed to participate in the study and signed an informed consent before participating in any research-related activities.
Ability to comply with research visits and other programme requirements
Exclusion Criteria:
The patient did not receive standard pancreaticoduodenectomy.
Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass grafting, New York Heart Association (NYHA) grade III-IV heart failure, cerebrovascular accident, transient ischemic attack or epileptic seizure 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 or psychiatric disorders;
The patient's access to any other clinical study or to a trial of an interventional drug 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cong Wang, MM
Phone
+8613752570372
Email
wangcongalex@126.com
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Cong, Master
Phone
86-13752570372
Email
wangcongalex@126.com
12. IPD Sharing Statement
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Ear Acupuncture Preventing Delayed Gastric Emptying.
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