Multicentre randomised controlled trial of a self-assembling haemostatic gel to prevent delayed bleeding following endoscopic mucosal resection (PURPLE Trial).

We aimed to evaluate if the prophylactic application of a haemostatic gel to the resection field directly after EMR can reduce the rate of clinically significant delayed bleeding events.

我们的目标是评估在EMR后直接向切除区域预防性应用止血凝胶是否可以降低临床上显著的延迟性出血事件的发生率。

Methods

We conducted a prospective randomised trial of patients undergoing hot-snare EMR of flat lesions in the duodenum (≥10 mm) and colorectum (≥20 mm) at 15 German centres.

我们在15个德国中心进行了一项前瞻性随机试验，研究对象为接受十二指肠（≥10毫米）和结直肠（≥20毫米）平坦病变热圈套内镜下黏膜切除术的患者。

Prophylactic clip closure was not allowed, but selective clipping or coagulation could be used prior to randomisation to treat intraprocedural bleeding or for prophylactic closure of visible vessels.

不允许进行预防性夹闭，但在随机分组前，可以使用选择性夹闭或凝固术来治疗术中出血或预防性闭合可见的血管。

Patients were randomised to haemostatic gel application or no prophylaxis.

患者被随机分配至止血凝胶应用组或无预防措施组。

The primary endpoint was delayed bleeding within 30 days.

主要终点是30天内的延迟性出血。

Results

The trial was stopped early due to futility after an interim analysis.

由于中期分析显示无效，试验提前终止。

The primary endpoint was analysed in 232 patients (208 colorectal, 26 duodenal).

主要终点在232名患者中进行了分析（208名结直肠癌患者，26名十二指肠癌患者）。

Both groups were comparable in age, sex, comorbidities and lesion characteristics.

两组在年龄、性别、合并症和病变特征方面具有可比性。

Preventive measures, such as selective clipping or coagulation, were applied prior to randomisation in 51.9% of cases, with no difference between groups.

在随机分组前，51.9%的病例已应用了预防性措施，如选择性夹闭或凝固，两组之间没有差异。

Delayed bleeding occurred in 14 cases (11.7%; 95% CI 7.1% to 18.6%) after Purastat and in 7 cases (6.3%; 95% CI 3.1% to 12.3%) in the control group (p=0.227), with no difference between colorectal and duodenal subgroups.

在使用Purastat的14例患者中（11.7%；95%置信区间7.1%至18.6%）和对照组的7例患者中（6.3%；95%置信区间3.1%至12.3%）发生了延迟性出血（p=0.227），结直肠和十二指肠亚组之间没有差异。

Conclusions

The application of a haemostatic gel following EMR of large flat lesions in the duodenum and colorectum does not reduce the rate of delayed bleeding.

在十二指肠和结直肠大平坦病变的内镜下黏膜切除术（EMR）后应用止血凝胶，并没有降低延迟性出血的发生率。