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GastroEndoNews.com

The recently developed minimally invasive anti-obesity procedure, primary obesity surgery endoluminal 2.0, can reverse nonalcoholic fatty liver disease, according to a controlled trial.

“There were improvements in multiple metabolic parameters, and steatosis resolved in most patients” during the study, according to Maryam Al Khatry, MD, the head of the GI Endoscopy Department at Ibrahim Bin Hamad Obaidullah Hospital, in United Arab Emirates, who performed the study in collaboration with Barham Abu Dayyeh, MD, the director of advanced endoscopy at Mayo Clinic in Rochester, Minn.

Short, Incisionless Procedure

The endoscopic POSE 2.0 procedure has shown efficacy in achieving weight loss in obese patients, including in a multicenter prospective trial published earlier this year (Clin Gastroenterol Hepatol 2022 May 6. doi:10.1016/j.cgh.2022.04.019). The procedure involves performing full-thickness gastric body plications to shorten and narrow the stomach. It does not require incisions and can be completed within an hour.

In Dr. Al Khatry’s prospective controlled trial, adults with obesity at Ibrahim Bin Hamad Obaidullah Hospital elected to undergo the POSE 2.0 procedure with lifestyle modifications or be managed with lifestyle modifications alone. There were no statistical differences in the baseline characteristics of the 20 patients who underwent POSE 2.0 and the 22 patients who elected to be managed with lifestyle interventions alone. Half of the patients were female, and the mean age was 32.4 years. The mean body mass index was 37.9 kg/m2.

The two co-primary end points were the resolution of steatosis as assessed by FibroScan (Echosens) and improvement in the controlled attenuation parameter (CAP), which employs vibration-controlled transient elastography as a surrogate for histologic steatosis grade.

Presenting the data at Digestive Disease Week 2022 (abstract 79), Dr. Al Khatry reported that on the FibroScan analysis, steatosis resolved at 12 months in 52.6% of those who underwent POSE 2.0 versus 0% of those managed with lifestyle modifications (P<0.001). For the CAP end point, the value fell from a mean baseline value of 338.0 to 235.5 in those who underwent the bariatric procedure. This 30% reduction was highly significant (P<0.0001). No significant reduction from baseline was seen in the lifestyle arm.

Total body weight loss, a secondary end point, was 17.5% in the POSE 2.0 arm and 4.0% in the lifestyle arm (P=0.001). Elevated aspartate aminotransferase (P=0.04) and the hepatic steatosis index (P=0.001) also were significantly improved after POSE 2.0 but not after lifestyle modifications alone.

Alternative to Traditional Bariatric Procedures

There is promise for novel treatments of NAFLD in development, but weight loss is now the only reliable intervention for NAFLD, creating an important need for anti-obesity surgeries and endoscopic procedures that are safe and not difficult to perform, Dr. Al Khatry noted.

“Greater than 10% total body weight loss is a reliable treatment modality associated with histologic resolution of steatohepatitis and fibrosis regression, but this magnitude of weight loss is uncommon [with] lifestyle modification alone,” Dr. Al Khatry pointed out.

Numerous studies have associated bariatric surgery with improvement of NAFLD. In a meta-analysis of 21 studies that included three different types of bariatric surgeries, liver fibrosis improved in 30%, steatohepatitis improved in 59% and steatosis improved in 88% (Surg Obes Relat Dis 2019;15[3]:502-511).

But since many eligible patients do not choose to undergo traditional bariatric procedures, POSE 2.0 may present an alternative option for them, according to Ravishankar Asokkumar, MBBS, a gastroenterologist in the Division of Gastroenterology and Hepatology at Singapore General Hospital, who has experience with the procedure. Dr. Asokkumar was a co-investigator on a study with one-year follow-up data on 46 patients who underwent POSE 2.0 published last year (Endoscopy 2021;53[11]:1169-1173).

“The current surgical procedures are effective but are not being widely accepted by patients,” Dr. Asokkumar told Gastroenterology & Endoscopy News. He said this is one factor contributing to the low rates of bariatric surgery relative to the proportion of the population who could benefit.

While “endoscopic procedures have a key role to play” in the effort to gain patient acceptance, he said he considers POSE 2.0 to be particularly well suited to fill an unmet need. “The procedure is easy to perform and the learning curve is short for those who already perform other endoscopic bariatric procedures,” he said.

In his own experience, it has been effective. “In our series of 75 patients followed for one year, the proportion of total body weight lost was 17.8%,” he reported. At two years, there was some weight gain, but “a significant proportion had maintained the weight reduction.” An endoscopic relook at two years, he added, showed the “suture plications of POSE 2.0 were still intact, offering persistent restrictive effect.”