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双极止血夹与标准治疗（即内镜下夹闭联合/不联合肾上腺素注射）治疗活动性非静脉曲张性上消化道出血的前瞻性随机多中心研究（BeBop 试验）：研究方案。

Bipolar haemostatic forceps versus standard therapy by haemoclip + / - epinephrine injection as initial endoscopic treatment in active non-variceal upper GI bleeding: study protocol for a prospective, randomized multicentre trial (BeBop-Trial).

机构信息

Department of Gastroenterology and Infectiology, Helios Kliniken Schwerin, University Campus of Medical School Hamburg, Wismarsche Str.393-397, Schwerin, 19055, Germany.

Department of Medical Statistics and Epidemiology, Medical School Hamburg, Am Kaiserkai 1, Hamburg, 20457, Germany.

出版信息

Trials. 2023 Jun 15;24(1):407. doi: 10.1186/s13063-023-07394-x.

DOI:10.1186/s13063-023-07394-x

PMID:37322511

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10268387/

Abstract

BACKGROUND

Patients with active nonvariceal upper gastrointestinal bleeding (NVUGIB) usually require urgent endoscopic treatment. Standard therapy (ST) using haemoclip + / - epinephrine injection is not always successful. Bipolar haemostatic forceps (HemoStat/Pentax®) are an approved medical device for the treatment of gastrointestinal bleeding. However, their use as a primary endoscopic treatment for active NVUGIB has not yet been proven in a randomized prospective study.

METHODS

This is a prospective, randomized, multicentre superiority trial (n ≥ 5). Patients with active NVUGIB will be randomized (1:1) to ST and to experimental therapy (ET) by application of bipolar haemostatic forceps. In the case of failed initial treatment within 15 min, crossover treatment will be attempted first. Rescue treatment (e.g. via over-the-scope-clip) will then be allowed after 30 min. All patients will also receive standard therapy with proton pump inhibitors. Forty-five patients per treatment arm are required to demonstrate an absolute difference of 25.4% with a power of 80% and a significance level of 0.05.

DISCUSSION

The hypothesis of the study is that bipolar haemostatic forceps are superior to ST in terms of successful primary haemostasis and the absence of recurrent bleeding within 30 days (combined endpoint). The 1:1 randomization is also ethically justifiable for this study, as both procedures are approved for the intervention in question. To further increase the safety of the patients in the study, crossover treatment and rescue treatment are planned. The prospective design seems feasible in a reasonable time frame (recruitment period of 12 months), as nonvariceal upper gastrointestinal bleeding is common. Anticoagulants and/or antiplatelet drugs could be an important confounding factor in the statistical analysis that needs to be taken into account and calculated if necessary. In conclusion, this randomized, prospective, multicentre study could make an important contribution to answering the question of whether bipolar haemostatic forceps could be the first-line therapy in the endoscopic treatment of stage Forrest I a + b NVUGIB.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05353062. Registered on April 30 2022.

摘要

背景

患有活动非静脉曲张性上消化道出血（NVUGIB）的患者通常需要紧急内镜治疗。使用止血夹+/-肾上腺素注射的标准治疗（ST）并非总是有效。双极止血钳（HemoStat/Pentax®）是一种已批准用于治疗胃肠道出血的医疗设备。然而，它们作为治疗活动 NVUGIB 的主要内镜治疗方法尚未在随机前瞻性研究中得到证实。

方法

这是一项前瞻性、随机、多中心优效性试验（n≥5）。将患有活动 NVUGIB 的患者随机（1:1）分为 ST 组和双极止血钳实验组。如果 15 分钟内初始治疗失败，将首先尝试交叉治疗。如果 30 分钟后仍未止血，将允许进行挽救性治疗（例如通过过镜夹）。所有患者还将接受质子泵抑制剂的标准治疗。每个治疗组需要 45 例患者，以证明在 30 天内达到 25.4%的绝对差异，置信度为 80%，显著性水平为 0.05。

讨论

该研究的假设是，在初次止血成功和 30 天内无复发性出血方面（联合终点），双极止血钳优于 ST。对于这项研究，1:1 的随机分组在伦理上也是合理的，因为这两种程序都被批准用于所讨论的干预。为了进一步提高研究患者的安全性，计划进行交叉治疗和挽救性治疗。在合理的时间框架内（招募期为 12 个月），前瞻性设计似乎是可行的，因为非静脉曲张性上消化道出血很常见。抗凝剂和/或抗血小板药物可能是统计分析中的一个重要混杂因素，需要考虑在内，并在必要时进行计算。总之，这项随机、前瞻性、多中心研究可能对回答双极止血钳是否可以成为内镜治疗 Forrest I a+b 期 NVUGIB 的一线治疗方法这一问题做出重要贡献。