December 1, 2009 — 糖尿病手術高級會議(Diabetes Surgery Summit，DSS)共識研討會回顧相關研究，並做出有關以胃部手術治療第2型糖尿病(type 2 diabetes mellitus，T2DM)的臨床建議。這個新的立場聲明，與臨床及研究議題的建議一致，也與糖尿病手術的整體觀念和定義一致，發表於11月19日線上第一版的外科醫學誌(Annals of Surgery)。
DSS接受Covidien、Ethicon、Allergan、Storz、GI Dynamics、Roche、Amylin以及Power Medical Interventions等的支持。
Ann Surg. 線上發表於2009年11月19日。
Recommendations Issued for Use of Gastrointestinal Surgery to Treat Type 2 Diabetes
By Laurie Barclay, MD
Medscape Medical News
December 1, 2009 — The Diabetes Surgery Summit (DSS) Consensus Conference reviewed pertinent research and made clinical recommendations regarding gastric surgery as a treatment of type 2 diabetes mellitus (T2DM). The new position statement, which consists of recommendations for clinical and research issues, as well as overall concepts and definitions in diabetes surgery, is published in the November 19 Online First issue of Annals of Surgery.
"Increasing evidence demonstrates that bariatric surgery can dramatically ameliorate type 2 diabetes," write Francesco Rubino, MD, from Weill Cornell Medical College/New York Presbyterian Hospital, New York, NY, and colleagues from the DSS Delegates. "Not surprisingly, gastrointestinal operations are now being used throughout the world to treat diabetes in association with obesity, and increasingly, for diabetes alone. However, the role for surgery in diabetes treatment is not clearly defined and there are neither clear guidelines for these practices nor sufficient plans for clinical trials to evaluate the risks and benefits of such 'diabetes surgery.'"
Development of Position Statement
The goal of this consensus conference was to issue guidelines for the use of gastrointestinal surgery for treatment of patients with T2DM and to develop a plan for further research. The DSS consensus document aimed to include the foundations underlying "diabetes surgery" and to present the opinions of leading scholars and evidence base supporting better access to surgical options, while preventing harm from unwarranted use of unproven procedures.
At the first International Conference on Gastrointestinal Surgery to Treat Type 2 Diabetes (the DSS), a multidisciplinary group of 50 voting delegates from around the world were convened in Rome, Italy, to review available scientific evidence. These data were evaluated and critiqued by the entire group to determine the strength of evidence and to draft consensus statements.
Draft statements from this meeting were reviewed, debated, edited, reevaluated, and presented for formal voting. Those statements that achieved consensus were summarized and distributed to all voting delegates for further input and final approval. At the 1st World Congress on Interventional Therapies for T2DM held in New York in September 2008, the final consensus statements were reviewed and discussed by representatives of several scientific societies to generate the current position statement.
The DSS acknowledged that in carefully selected patients, surgical approaches to treat T2DM are appropriate. In patients with poorly controlled diabetes and a body mass index (BMI) of 30 kg/m2 or more, for example, gastric bypass was recognized to be a reasonable treatment option.
Specific procedures may include Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding, or biliopancreatic diversion.
The DSS recommended further clinical trials to determine the precise role of surgery in patients who have less severe obesity and diabetes. Also strongly needed is further research on the mechanisms underlying surgical control of diabetes, which may further elucidate the pathophysiology of diabetes.
Recommendations
Specific recommendations in the DSS position statement, and their accompanying level of evidence rating, include the following:
In acceptable surgical candidates with a BMI of 35 kg/m2 or more whose disease is inadequately controlled by lifestyle and medical therapy, gastrointestinal surgery, such as RYGB, laparoscopic adjustable gastric banding, or biliopancreatic diversion, should be considered for the treatment of T2DM (level of evidence, A).
In suitable surgical candidates with mild to moderate obesity (BMI 30 - 35 kg/m2), a surgical approach may also be appropriate as a nonprimary option to treat inadequately controlled T2DM (level of evidence, B). RYGB may be an appropriate surgical option to treat diabetes in these patients (level of evidence, C).
In early clinical studies, novel gastrointestinal surgical techniques (eg, duodenal-jejunal bypass, ileal interposition, sleeve gastrectomy, and endoluminal sleeves) have shown promising results for the treatment of T2DM. At present, however, they should be used only in the context of institutional review board–approved and registered trials (level of evidence, A).
Establishing standards to measure clinical and physiologic outcomes of surgical treatment for T2DM is a high priority to obtain better-quality medical evidence (level of evidence, A).
To evaluate the usefulness of gastrointestinal surgery to treat T2DM, the DSS strongly encourages more randomized controlled trials (level of evidence, A).
Another important research priority is to identify the appropriate use of gastrointestinal surgery to treat T2DM in patients with a BMI of less than 35 kg/m2 (level of evidence, A). This should be accomplished with controlled clinical trials to assess the safety and efficacy of gastrointestinal metabolic surgery (level of evidence, A) and to identify parameters other than BMI to help guide selection of suitable patients (level of evidence, A).
Defining the optimal use of gastrointestinal surgery for treatment of T2DM in patients with a BMI of less than 35 kg/m2 would also be greatly facilitated by development of a standard registry/database (level of evidence, A).
Animal models can also offer helpful insights regarding the efficacy and mechanisms of gastrointestinal metabolic surgery used to treat T2DM (level of evidence, A).
Research on gastrointestinal metabolic surgery offers valuable, novel opportunities to investigate contributions of the gastrointestinal tract to glucose homeostasis and to clarify the pathophysiologic mechanisms of T2DM (level of evidence, A).
After laparoscopic adjustable gastric banding, weight loss alone accounts for diabetes control, based on available evidence from animal and clinical studies (level of evidence, A). However, mechanisms beyond those related to lowered food intake and body weight seem to be involved in intestinal bypass procedures such as RYGB, biliopancreatic diversion, and duodenal-jejunal bypass (level of evidence, A). In addition, distinct physiologic mechanisms that ameliorate T2DM are activated by anatomic changes in different regions of the gastrointestinal tract (level of evidence, B).
To improve understanding of gastrointestinal mechanisms of metabolic regulation and to use these insights to improve T2DM treatment, collaboration should be encouraged among endocrinologists, surgeons, and basic scientists (level of evidence, A).
To oversee the study and development of diabetes surgery, a multidisciplinary task force should be established, including endocrinologists, surgeons, clinical and basic investigators, bioethicists, and other appropriate experts (level of evidence, A).
"Delegates unanimously agreed that patients with inadequately controlled diabetes and BMI >35 kg/m2 should be considered for GI [gastrointestinal] surgery," the DSS authors conclude. "This concurs with existing NIH [National Institutes of Health] guidelines and with the 2009 American Diabetes Association standards of care position statement, and it further emphasizes the role of GI surgery in severely obese patients, where mounting evidence shows that surgery improves overall survival."
DSS was supported by Covidien, Ethicon, Allergan, Storz, GI Dynamics, Roche, Amylin, and Power Medical Interventions.
