Auricular Acupoint EmbeddingNCT04118881
Ear Acupuncture Preventing Delayed Gastric Emptying.
A study testing Ear Acupuncture in people with Auricular Acupoint Embedding and Pancreaticoduodenectomy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Auricular Acupoint Embedding, Pancreaticoduodenectomy, Delayed Gastric Emptying
- What is being tested?
- Ear Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2019to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- Acupuncture and moxibustion is currently used or used in the past 30 days.
- Ear trauma or unhealed ear wound
- Stainless steel allergists
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Wang Cong, Master, 86-13752570372, wangcongalex@126.com
About this study
Official title: Preoperative Ear Acupuncture to Prevent Delayed Gastric Emptying After Pancreatoduodenectomy.A Single-center Prospective Randomized Controlled Clinical Study.
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.
- Being tested
- Ear Acupuncture
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The treatment group was given intradermal needling at ear acupoints: cardia (CO3), stomach (CO4), sympathetic (HX4) Receives: Other: Ear Acupuncture |
| control group | Sham comparator | The control group was given intradermal needling at ear acupoints: spiral area (HX7 and HX8). Receives: Other: Ear Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day3 after operation
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.
Measured: Day5 after operation
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.
Measured: Day7 after operation
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.
Measured: Day14 after operation
Secondary outcomes (2)
Changes of motilin before and after operation
Serum motilin was measured at Day0 and Day7 after operation.
Measured: Day0 and Day7 after operation.
Changes of somatostatin before and after operation
Somatostatin were measured at Day0 and Day7 after operation.
Measured: Day0 and Day7 after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Oct 2019 (estimated)
- Primary completion2 Aug 2021 (estimated)
- Study completion2 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular Acupoint EmbeddingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118881
- Sponsor's protocol ID
- E2019158A
- Status last verified
- Aug 2019
- First submitted
- 26 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ear Acupuncture to Prevent Delayed Gastric Emptying After Pancreatoduodenectomy.A Single-center Prospective Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT04118881
- Acronym / sponsor ID
- E2019158A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 Oct 2019 (estimated)
- Primary completion
- 2 Aug 2021 (estimated)
- Study completion
- 2 Dec 2021 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: Ear AcupunctureThe treatment group was given intradermal needling at ear acupoints: cardia (CO3), stomach (CO4), sympathetic (HX4) |
| control group | Sham comparator | Other: Ear AcupunctureThe control group was given intradermal needling at ear acupoints: spiral area (HX7 and HX8). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear AcupunctureAuricular 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. | Other | control group, treatment group |
Primary outcome
Grading of delayed gastric emptying
Time frame: Day3 after operation
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
Time frame: Day5 after operation
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
Time frame: Day7 after operation
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
Time frame: Day14 after operation
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.
2 secondary outcomes
Changes of motilin before and after operation
Time frame: Day0 and Day7 after operation.
Changes of somatostatin before and after operation
Time frame: Day0 and Day7 after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear Acupuncture in people with Auricular Acupoint Embedding and Pancreaticoduodenectomy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cong Wang, MM (+8613752570372, wangcongalex@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of delayed gastric emptying (time frame: Day3 after operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.