Pichamol Jirapinyo, MD, MPH, director of bariatric endoscopy fellowship at Brigham and Women's Hospital, explains the implications of her study on the effects of endoscopic gastric plication on liver fibrosis in patients with nonalcoholic steatohepatitis (NASH).
About a year after patients with obesity and nonalcoholic fatty liver disease (NAFLD) underwent an endoscopic gastroplication procedure, their amount of liver fibrosis significantly decreased, according to a study led by Pichamol Jirapinyo, MD, MPH, director of bariatric endoscopy fellowship at Brigham and Women's Hospital.
In an interview with The American Journal of Managed Care® (AJMC®), Jirapinyo discusses the study’s design, findings, and steps to prevent NAFLD from developing into nonalcoholic steatohepatitis (NASH). This interview is edited lightly for clarity.
AJMC®: Can you explain the design of your study on the effects of endoscopic gastric plication on liver fibrosis in patients with NASH, as well as how endoscopic gastric plication 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. Additionally, patients needed to have clinically significant hepatic fibrosis, which was defined as fibrosis stage of F2 and above. Endoscopic gastric plication procedure, essentially, is a type of endoscopic weight loss procedure where we use an endoscopic stapling device to reduce the volume of the stomach by about two thirds.
AJMC®: How is endoscopic gastric plication different from other treatments currently available for patients with NASH?
Right now, the main therapy for patients with NASH actually is limited to only lifestyle intervention, like specifically diet and exercise to induce weight loss to help with NASH. Bariatric surgery has been performed for patients with obesity, but then studies have shown that [it also has] benefits on NASH. [Endoscopic gastric plication] is different from them both because it's an endoscopic option, so it's not surgery. And this procedure has been shown to cause weight loss; however, no one has studied the effect of this procedure on NAFLD/NASH.
AJMC®: What were the key findings of this study?
At about 1 year after endoscopic gastroplication procedure, the amount of fibrosis, which was measured using FibroScan, significantly decreased. Specifically, the liver stiffness measurement decreased from 14.2 kilopascals to 8.9 kilopascals. Additionally 68% of our patient cohort experienced regression of fibrosis by at least 1 stage. Additionally, in the secondary outcomes, we showed that there are surrogates of fatty liver disease including NFS [NAFLD Fibrosis Score], FIB-4, ALT [alanine transaminase], and CAP [controlled attenuation parameter] score also significantly improved at 1 year following this procedure.
AJMC®: Did any of the findings surprise you?
The finding that was interesting to me was the fibrosis because, in this study, we included patients with clinically significant hepatic fibrosis—F2 to F4—and it's known that for patients with more advanced fibrosis, usually it's more difficult for the fibrosis stage to regress. However, in our study, up to 68% of the patients were able to regress or experience regression of fibrosis by at least 1 stage. So, that was surprising in a good way.
AJMC®: How can these findings of this treatment be applied to patients with NASH and other conditions?
One thing that I can highlight is that NASH is a spectrum of disease, and a subgroup of patients actually progress to NASH and cirrhosis. In our study, we did include patients with compensated NASH cirrhosis, and we also found that these patients have improvement in hepatic fibrosis, which is very great news because usually [patients with advanced fibrosis] have very limited options, because bariatric surgery may not be an option for them. So, it's nice that they can get this procedure, less invasive, get weight loss, and also have improvement in hepatic fibrosis.
AJMC®: Because weight loss played a major role in this study, how did you ensure a diverse population in terms of body type or weight?
We enrolled patients with any classes of obesity. Obesity is classified into class 1, which is BMI [body mass index] of 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 the patients that were enrolled had class 3 obesity. So essentially, we showed that this procedure was safe and also effective at improving NAFLD in all classes of obesity.
AJMC®: What can patients do to prevent NASH before they receive a diagnosis?
One of the risk factors for NASH is obesity. So it comes down to prevention of obesity, weight gain, and/or if patients are classified in the obesity category already, it's important for the patients and also for the primary care doctors to recognize obesity early and then start treatment early. Treatment options for obesity alone, you can do lifestyle intervention, pharmacotherapy, or bariatric endoscopy which is available for patients starting at a BMI of 30, which is lower than the criteria for bariatric surgery.
AJMC®: What steps can be taken to reduce disparities in obesity, and therefore reduce disparities in NASH diagnoses and treatment?
Education regarding lifestyle in general, like with diet and exercise, I think that will be 1 way at the patient population [level] to prevent obesity and NASH pandemic.
From a treatment standpoint, we already know that there are a lot of people out there who have NASH, but may not be aware. It's been known that up to 80% to 90% of the patients who have obesity actually have NAFLD, but this might not be recognized because there's no symptom; unless you actually look for it, you won't know you have fatty liver. The majority of my patients come in asking for weight loss therapy, and I work with them and that's how we found out that they actually also have fatty liver.
I think the second thing besides education at the patient population level, number 2 is at the provider level where people should be looking for fatty liver more. If you see any patients with BMI greater than 30, look for fatty liver because it's common. Additionally, if you have diabetes, this increases the risk of fatty liver even more, so then you will start diagnosing more patients. Number 3, you can start treatment early for these patients. And the treatment, like I said, basically come with the weight loss therapies, so lifestyle intervention, medications, bariatric endoscopy, bariatric surgery.
Now, the last step, which is the fourth step, to do less action items. From this study, we know that bariatric endoscopy, which traditionally has been the treatment option for weight loss, now we show that it can also help with fatty liver. So we should be teaching and training more endoscopists to be able to do this procedure well so that we can increase the supply, because we know the demand and the number of patients who have NASH or NAFLD is a lot, but we also need to train people up so that they can do these procedures to fight this pandemic.