Abstract：
Bariatric surgery is the most effective treatment for obesity but is invasive and associated with serious complications. Endoscopic sleeve gastroplasty (ESG) is a less invasive weight loss procedure to reduce the stomach volume by full-thickness sutures. ESG has been adopted in many countries, but implementation at Scandinavian centres has not yet been documented. We performed a clinical pilot trial at a Norwegian centre with the primary objective to assess the feasibility of the ESG procedure.
We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40-49.9 kg/m2, BMI 35-39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30-34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits.
All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1-16.2) and 9.1% (95% CI 3.3 - 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively.
This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period.
We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40-49.9 kg/m2, BMI 35-39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30-34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits.
All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1-16.2) and 9.1% (95% CI 3.3 - 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively.
This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period.
摘要：
■减肥手术是治疗肥胖最有效的方法，但具有侵入性，并伴有严重的并发症。内窥镜套管胃成形术（ESG）是一种侵入性较小的减肥程序，可通过全厚度缝线减少胃体积。ESG已在许多国家采用，但斯堪的纳维亚中心的实施情况尚未记录在案。我们在挪威中心进行了一项临床试点试验，主要目的是评估ESG程序的可行性。
■我们将在挪威中心接受ESG治疗的前10名患者纳入单臂试点研究。合格标准是体重指数（BMI）为40-49.9kg/m2，BMI为35-39.9kg/m2以及至少一种与肥胖相关的合并症。或BMI30-34.9kg/m2和2型糖尿病。患者随访类似于该中心用于减肥手术的方案，包括饮食计划和门诊就诊。
■所有手术在技术上都是成功的，除了一名患者胃部和前腹壁有粘连，与之前的疝气修复有关,导致胃体积减少少于预期。26周和52周后的平均总体重减轻（TBWL）为12.2%（95%CI8.1-16.2）和9.1%（95%CI3.3-15.0）。一名患者经历了轻微的缝线诱导的膈肌损伤，这是成功的保守管理。
■这是斯堪的纳维亚第一个ESG临床试验，记录该程序在挪威中心的执行情况，证明了可接受的可行性和安全性，在52周的随访期间，个体体重减轻的差异很大。
■我们将在挪威中心接受ESG治疗的前10名患者纳入单臂试点研究。合格标准是体重指数（BMI）为40-49.9kg/m2，BMI为35-39.9kg/m2以及至少一种与肥胖相关的合并症。或BMI30-34.9kg/m2和2型糖尿病。患者随访类似于该中心用于减肥手术的方案，包括饮食计划和门诊就诊。
■所有手术在技术上都是成功的，除了一名患者胃部和前腹壁有粘连，与之前的疝气修复有关,导致胃体积减少少于预期。26周和52周后的平均总体重减轻（TBWL）为12.2%（95%CI8.1-16.2）和9.1%（95%CI3.3-15.0）。一名患者经历了轻微的缝线诱导的膈肌损伤，这是成功的保守管理。
■这是斯堪的纳维亚第一个ESG临床试验，记录该程序在挪威中心的执行情况，证明了可接受的可行性和安全性，在52周的随访期间，个体体重减轻的差异很大。
