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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | The treatment group was given intradermal needling at ear acupoints: cardia (CO3), stomach (CO4), sympathetic (HX4) |
|
| control group | Sham Comparator | The control group was given intradermal needling at ear acupoints: spiral area (HX7 and HX8). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ear Acupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Day14 after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of motilin before and after operation | Serum motilin was measured at Day0 and Day7 after operation. | Day0 and Day7 after operation. |
| Changes of somatostatin before and after operation | Somatostatin were measured at Day0 and Day7 after operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Wang, MM | Contact | +8613752570372 | wangcongalex@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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|
| Day0 and Day7 after operation. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |