驚きである。

胃瘻は食べることが出来ない患者に対し、胃に直接栄養を補給するために開発された。

しかし、今や、肥満者に対し、食べた栄養を抜くために用いられるようになった。
 

その最初の報告（パイロットスタディ）は、2013年にワシントン大学から報告された。

Gastroenterology. 2013 Dec; 145(6): 1245–52.e1-5.

Aspiration Therapy Leads to Weight Loss in Obese Subjects: A Pilot Study

Shelby Sullivan,¹ Richard Stein,² Sreenivasa Jonnalagadda,¹ Daniel Mullady,¹ and Steven Edmundowicz¹

¹Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri

²Divisions of Geriatrics and Nutritional Science, Washington University School of Medicine, St Louis, Missouri

Background & Aims

Obese patients rarely achieve long-term weight loss with only lifestyle interventions. We evaluated the use of endoscopic aspiration therapy for obesity. Aspiration therapy involves endoscopic placement of a gastrostomy tube (A-Tube) and the AspireAssist siphon assembly (Aspire Bariatrics, King of Prussia, PA) to aspirate gastric contents 20 minutes after meal consumption.

Methods

We performed a pilot study of 18 obese subjects who were randomly assigned (2:1) to groups that underwent aspiration therapy for 1 year plus lifestyle therapy (n = 11; mean body mass index, 42.6 ± 1.4 kg/m²) or lifestyle therapy only (n = 7; mean body mass index, 43.4 ± 2.0 kg/m). Lifestyle intervention comprised a 15-session diet and behavioral education program.

Results

Ten of the 11 subjects who underwent aspiration therapy and 4 of the 7 subjects who underwent lifestyle therapy completed the first year of the study. After 1 year, subjects in the aspiration therapy group lost 18.6% ± 2.3% of their body weight (49.0% ± 7.7% of excess weight loss [EWL]) and those in the lifestyle therapy group lost 5.9% ± 5.0% (14.9% ± 12.2% of EWL) (P < .04). Seven of the 10 subjects in the aspiration therapy group completed an additional year of therapy and maintained a 20.1% ± 3.5% body weight loss (54.6% ± 12.0% of EWL). There were no adverse effects of aspiration therapy on eating behavior and no evidence of compensation for aspirated calories with increased food intake. No episodes of binge eating in the aspiration therapy group or serious adverse were reported.

Conclusions

In a pilot study, aspiration therapy appears to be a safe and effective long-term weight loss therapy for obesity

胃へのチューブの留置は内視鏡的胃瘻造設法によって行われた。

チューブサイズは20～24フレンチ（クック社）。
 

朝食、昼食、夕食それぞれの20分後に、150～200㏄の水を注入し、その後、液を排除する方法が、10分間以内行い、摂取カロリーの約30％が除去された。

食事や運動などのライフスタイル療法と比較した結果は以下であった。

 

・・・・・・・・・・・・・・・・・・

 

そして、2016年6月14日、FDAはこの治療について承認することを決定した。

http://www.medscape.com/viewarticle/864800

AspireAssist Obesity Device Approved by FDA

Troy Brown, RN

The US Food and Drug Administration (FDA) has approved the AspireAssist (Aspire Bariatrics) obesity-treatment device, which will allow patients to drain part of their stomach contents after each meal, preventing the absorption of approximately 30% of calories consumed.

The device consists of a tube that is endoscopically placed through an incision in the skin into the stomach and a disk-shaped port valve that is placed outside the body, flush with the abdominal skin. Approximately 20 to 30 minutes after eating, the patient attaches the device's external connector and tubing to the port valve, opens the valve and drains the contents into the toilet. The process takes approximately 5 to 10 minutes.

"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight-management therapy," William Maisel, MD, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in an FDA news release. "Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake."

The device is intended for use in obese patients aged 22 years or older with a body mass index of 35 to 55 who have tried and failed to lose weight through nonsurgical weight-loss therapy. It should not be used for short-term durations in moderately overweight individuals or in patients with eating disorders.

The decision follows a review of data from a clinical trial of 111 patients treated with the device and lifestyle moderation and 60 control patients who received lifestyle therapy only. After 1 year, those who used the AspireAssist device lost an average of 12.1% of their total body weight, compared with 3.6% for those in the control group. Patients in both groups had small improvements in obesity-associated conditions including diabetes, hypertension, and quality of life. "These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling," the FDA explained in the news release.

Patients must be monitored closely; the device automatically stops working after 115 cycles, or approximately 5 to 6 weeks of therapy, to ensure that the patient returns for medical follow-up and a replacement part for the device. The tube must be shortened as the patient's abdominal girth shrinks so that the disk remains flush with the skin. Patients also require ongoing counseling on lifestyle modification.

Side effects include occasional indigestion, nausea, vomiting, constipation, and diarrhea.

Risks

Risks associated with endoscopic surgical placement of the gastric tube include sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the abdominal lining, sores inside the stomach, pneumonia, unintended puncture of the stomach or intestinal wall, and death.

A number of risks related to the abdominal opening for the port valve may necessitate removal of the device. These include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site of the tube placement, leakage, bleeding and/or infection around the site where the tube is placed, and migration of the device into the stomach wall. Persistent fistula (an abnormal passageway between the stomach and the abdominal wall) may occur after the device is removed.

Contraindications

Contraindications for the device include uncontrolled hypertension, diagnosed bulimia or binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease, or stomach ulcers. The device is also contraindicated in those with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain, or patients with a high risk for medical complications from an endoscopic procedure.



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http://www.nbcnews.com/health/health-news/fda-approves-weight-loss-stomach-pump-aspireassist-combat-obesity-n592141

FDA Approves Weight Loss Stomach Pump AspireAssist to Combat Obesity

by MAGGIE FOX

The Food and Drug Administration approved a new and unusual weight loss device Tuesday: an external pump that dumps part of the stomach contents into the toilet.

Some critics have called it "assisted bulimia" but the device, approved for use in very obese patients, helps them lose on average more than 12 percent of body weight — far more than pills or most diets.

The device is considered minimally invasive and includes a tube that goes from the inside of the stomach to a port on the outside of the abdomen. The pump can be attached to the outside port as needed to remove about a third of the stomach's contents at a time.

Aspire Bariatrics of King of Prussia, Pennsylvania, which makes the device, has a video about it here.

Clinical trials showed patient lost an average of 46 pounds during the first year and another few pounds to make 50 pounds of weight loss by the second year.

"The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight," the FDA said in a statement.

＜動画＞
 

https://www.youtube.com/watch?v=nC6FkP5JZVk

AspireAssist: New, Reversible Weight Loss Procedure