Pichamol Jirapinyo, MD, MPH, director of the Bariatric Endoscopy Fellowship at Brigham and Women’s Hospital, explains the implications of her study on the effects of endoscopic gastric folding on cirrhosis in patients with nonalcoholic steatohepatitis (NASH).
After about a year of obesity and non-alcoholic fat patients Liver disease (NAFLD) underwent laparoscopic gastroplasty, and the amount of cirrhosis was significantly reduced, according to A study led by Pichamol JirapinyoMD, MPH, director of the Bariatric Endoscopy Fellowship at Brigham and Women’s Hospital.
In an interview with American Journal of Managed Care® (AJMC®), Jirapinyo discusses the study design, results, and steps to prevent NAFLD from progressing to nonalcoholic steatohepatitis (NASH). This interview has been lightly edited for clarity.
AJMC®: Can you explain your study design on the effects of laparoscopic gastroplasty on cirrhosis of nonalcoholic steatohepatitis patients, as well as how endoscopic gastroplasty works?
Our study was a single-center, prospective observational study. We included patients with obesity and NAFLD, which we defined as hepatic steatosis on imaging or histology without other causes of fatty liver. In addition, patients needed to have clinically significant cirrhosis, which was defined as a cirrhotic stage of F2 and above. The Laparoscopic Gastric Plication procedure, basically, is a type of endoscopic weight loss procedure in which we use an endoscopic stapling device to reduce the size of the stomach by about two-thirds.
AJMC®: How is laparoscopic gastroplasty different from other treatments currently available for patients with nonalcoholic steatohepatitis?
Currently, the main treatment for patients with nonalcoholic steatohepatitis is limited to lifestyle interventions only, such as specifically diet and exercise to induce weight loss to help treat nonalcoholic steatohepatitis. Bariatric surgery was done for obese patients, but then studies showed it [it also has] Benefits on NASH. [Endoscopic gastric plication] It differs from both because it is a laparoscopic option, so it is not surgery. It has been proven that this procedure causes weight loss; However, no one has studied the effect of this procedure on NAFLD/NASH.
AJMC®: What are the main findings of this study?
At about 1 year after the laparoscopic gastric bypass procedure, the amount of fibrosis measured with FibroScan was significantly reduced. Specifically, the measure of liver stiffness decreased from 14.2 kPa to 8.9 kPa. In addition, 68% of our patient group experienced regression of fibrosis by at least one stage. In addition, in secondary outcomes, we showed that there are alternatives to fatty liver disease including NFS [NAFLD Fibrosis Score]FIB-4, ALT [alanine transaminase]and CAP [controlled attenuation parameter] The result also improved significantly at 1 year after this procedure.
AJMC®: Did any of the results surprise you?
The finding that was interesting to me was fibrosis because in this study, we included patients with clinically significant cirrhosis – F2 to F4 – and it is known that for patients with more advanced fibrosis it is usually difficult for the fibrosis stage to regress. However, in our study, up to 68% of patients were able to regress or experience at least one stage of fibrosis regression. So, that was surprising in a good way.
AJMC®: How can the results of this treatment be applied to patients with nonalcoholic steatohepatitis and other conditions?
One thing I can highlight is that NASH is a spectrum of diseases, and a subset of patients actually progress to NASH And the cirrhosis. In our study, we included patients with compensated NASH cirrhosis, and we also found that these patients had an improvement in cirrhosis, which is very good news because usually [patients with advanced fibrosis] They have very limited options, because bariatric surgery may not be an option for them. Therefore, it is good that they can perform this procedure, with minimal invasiveness, lose weight, as well as improve cirrhosis.
AJMC®: Because weight loss played a major role in this study, how do you ensure that the population is diverse in terms of body type or weight?
We enrolled patients with any category of obesity. Obesity is classified into category 1, which is body mass index [body mass index] from 30 to 35; Class 2, which is 35 to 40; and Class 3, which is greater than 40. In our study, we included all classes, and in fact, about 50% of enrolled patients had Class III obesity. So basically, we showed that this procedure is also safe and effective in improving NAFLD in all obesity categories.
AJMC®: What can patients do to prevent nonalcoholic steatohepatitis before they are diagnosed?
Obesity is a risk factor for nonalcoholic steatohepatitis. It is therefore relevant to the prevention of obesity and overweight and/or if patients are already classified in the obesity category, it is important for patients as well as primary care physicians to recognize obesity early and then start treatment early. Bariatric treatment options alone, lifestyle intervention, drug therapy, or bariatric endoscopy are available for patients who start with a BMI of 30, which is below the criteria for bariatric surgery.
AJMC®: What steps can be taken to reduce obesity disparities, and thus disparities in the diagnosis and treatment of nonalcoholic steatohepatitis?
Education regarding lifestyle in general, as with diet and exercise, I believe that would be one way for the patient community [level] For the prevention of obesity and the NASH epidemic.
From a treatment point of view, we already know that there are a lot of people with nonalcoholic steatohepatitis, but they may not be aware of it. It is known that up to 80% to 90% of patients with obesity already have NAFLD, but this may not be recognized due to the absence of symptoms; Unless you actually look for it, you won’t know you have a fatty liver. The majority of my patients come to seek weight loss treatment, I work with them and so we found out that they do indeed have a fatty liver.
I think the second thing besides education at the patient population level, is number 2 at the provider level where people should be looking for fatty liver more. If you see any patient with a BMI greater than 30, look for fatty liver as it is common. Plus, if you have diabetes, this increases your risk of fatty liver even more, so you’ll start to diagnose more patients. Number 3, you can start treatment early for these patients. And the treatment, as I said, comes mainly with weight-loss therapies, so lifestyle intervention, medication, bariatric endoscopy, and bariatric surgery.
Now, the last step, which is the fourth step, to do less work items. With this study, we know that bariatric endoscopy, which has traditionally been a treatment option for weight loss, is now showing that it can also help treat fatty liver. So we have to educate and train more endoscopy specialists so that we can do this procedure well so that we can increase the supply, because we know that the demand and the number of patients who have NASH or NAFLD is very much, but we also need training so that they can do these procedures to combat this epidemic.