Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, People's Republic of China.
Endoscopy Center, East Hospital, Tongji University School of Medicine, Shanghai, China.
Surg Endosc. 2021 Oct;35(10):5675-5685. doi: 10.1007/s00464-020-08256-2. Epub 2021 Feb 4.
Endoscopic submucosal dissection (ESD) is a prominent minimally invasive operative technique for treating early gastrointestinal tumors but can result in postoperative bleeding. We conducted a randomized controlled trial to determine whether increasing blood pressure under hemostasis during gastric ESD to identify potential bleeding spots reduces the risk of post-ESD bleeding.
In this randomized, controlled, single-blinded clinical trial, 309 patients with early gastric cancer who were admitted to a hospital to undergo ESD were recruited from March 2017 to February 2018 and were randomized into intervention and control groups. In the control group, patients underwent normal ESD. In the intervention group, we increased patients' blood pressure to 150 mmHg for 5 min using a norepinephrine pump (0.05 μg/kg/min initial dose) after the specimen was extracted during the ESD operation to identify and coagulate potential bleeding spots with hot biopsy forceps. Our primary outcome was the incidence of postoperative bleeding over 60-day follow-up.
The incidence of post-ESD bleeding was lower in the intervention group (1.3%, 2/151) than in the control group (10.1%, 16/158, p = 0.01). Deeper tumor invasion was associated with a higher risk of post-ESD bleeding (5.3% in mucosal/submucosal layer 1 group vs. 12.5% in submucosal layer 2/muscularis propria group, p < 0.001). Multi-factor but not univariate analysis showed that proton pump inhibitor administration three times per day may be a better choice than twice per day.
Increasing blood pressure under hemostasis during ESD to identify and coagulate potential bleeding spots could reduce the risk of delayed bleeding after gastric ESD.
内镜黏膜下剥离术（ESD）是治疗早期胃肠道肿瘤的重要微创术式，但可导致术后出血。我们开展了一项随机对照试验，旨在确定在胃 ESD 止血时升高血压以识别潜在出血点是否会降低 ESD 后出血风险。
在这项随机、对照、单盲临床试验中，2017 年 3 月至 2018 年 2 月，我们招募了 309 例因早期胃癌入院接受 ESD 的患者，将其随机分为干预组和对照组。在对照组中，患者接受常规 ESD。在干预组中，我们在 ESD 操作中提取标本后，使用去甲肾上腺素泵将患者的血压升高至 150mmHg 并维持 5min（初始剂量为 0.05μg/kg/min），以使用热活检钳识别和凝固潜在的出血点。我们的主要结局是在 60 天随访期间发生术后出血的情况。
干预组的 ESD 后出血发生率（1.3%，2/151）低于对照组（10.1%，16/158，p=0.01）。肿瘤侵犯较深与 ESD 后出血风险较高相关（黏膜/黏膜下层 1 层组为 5.3%，黏膜下层 2/固有肌层组为 12.5%，p<0.001）。多因素而非单因素分析显示，一日三次给予质子泵抑制剂可能优于一日两次。
在 ESD 止血时升高血压以识别和凝固潜在出血点可降低胃 ESD 后迟发性出血的风险。
