麻豆传媒

Most patients with ongoing symptoms of delayed gastric emptying who were treated with gastric peroral endoscopic myotomy (G-POEM) were able to achieve long-term improvement, a researcher reported.

Among 46 patients with refractory gastroparesis, 65.2% achieved clinical success -- evidenced by a reduction in at least 1 point in the Gastroparesis Cardinal Symptom Index (GCSI) -- at 3 years after undergoing G-POEM, which remained stable over time, reported Jérémie Jacques, MD, PhD, of the Centre Hospitalier Universitaire in Limoges, France, at the Digestive Disease Week annual meeting.

Median GCSI scores (which range from 0-5; no symptoms to very severe) significantly fell from baseline to 3 years (3.3 vs 1.8, respectively), with similar reductions observed across subscales (P<0.0001 for all):

• Nausea: 2.7 vs 1.0
• Satiety: 3.8 vs 2.3
• Bloating: 4.3 vs 3.0

Prior trials with G-POEM have shown clinical success at 1 year for over two-thirds of patients with this chronic motility disorder that causes a delay in gastric emptying despite no signs of mechanical obstruction.

"We lack long-term data because most of the previous published studies were just interested in 1 year of clinical success," Jacques said.

Since the data are so limited on the safety, effectiveness, and durability of this emerging procedure, the 2020 guidelines recommended the use of G-POEM for "carefully selected patients only," and at expert centers.

Moreover, it is not known exactly which patients may benefit the most from the procedure, so Jacques's group sought to look for factors predictive of treatment success.

For their study, the researchers examined data on 46 patients with refractory gastroparesis treated with G-POEM at two French centers from 2015 to 2017. Two-thirds were women, and the mean age was 54. Only 5% had undergone previous interventions. Most had long symptom duration (58 months), and the median retention rate was 50% at 4 hours on gastric emptying scintigraphy.

When comparing G-POEM responders to non-responders, they found no significant differences between groups in terms of factors such as age, sex, gastric emptying, symptom duration, or nutritional status. However, significant differences were observed between responders and non-responders, respectively, on the following GCSI subscale scores: nausea (2.2 vs 3.0), satiety (3.8 vs 3.3), and bloating (4.4 vs 3.2).

Patients fell into one of four profiles: true responders to G-POEM, late responders, relapsers, or true failures. Among these groups, significant differences were seen for gastric retention at 4 hours on pre-operative gastric emptying scintigraphy. Additionally, true responders had higher satiety subscale scores, compared to all other groups. However, true responders and late responders had higher symptom scores.

Based on their findings, they developed a 4-point scoring system to predict G-POEM success at 3 years, where each of the following equates to 1 point:

• Nausea subscale score <2
• Satiety subscale score ≥4
• Bloating subscale score ≥3.5
• Retention at 4 hours >50%

A threshold of 2 points showed a sensitivity of 93%, a specificity of 56%, and an accuracy of 90.4% for G-POEM success. For example, those with a score of 2 or higher would have an 86.7% chance of success at 3 years, while those with a score of 0-1 would have a 70% chance of failure, Jacques explained.

As gastroparesis can be such a challenging and potentially devastating condition, news of therapeutic success is "most welcome," said Eamonn Quigley, MD, of Houston Methodist and past president of the American College of Gastroenterology.

"Testing this tool in a randomized sham-controlled study should be the next step, and consideration should be given to incorporating objective measures that might predict success, like assessments of pyloric distensibility with EndoFLIP technology," he added.

"My concern is that there are not enough details on the baseline characteristics of the patients," Matthew Kroh, MD, of the Cleveland Clinic in Ohio, told 麻豆传媒. "I would like to see more on the etiology of the disease in the score, not only preoperative symptoms, but other factors as well."

G-POEM "seems to work well with idiopathic patients, diabetic, and post-surgical patients," said Kroh, who was not involved in this study, noting that the idiopathic group appears to do better with the procedure.

Comment