Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): A Randomized Controlled Trial.

Surveillance endoscopy aims to detect early malignant progression; although widely practiced, it has not previously been tested in a randomized trial.

监测性内窥镜检查旨在检测早期恶性进展；尽管广泛实践，但之前并未在随机试验中进行过测试。

Methods

BOSS (Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study) was a randomized controlled trialat 109 centers in the United Kingdom.

BOSS（Barrett食管监测与按需内窥镜检查研究）是在英国109个中心进行的一项随机对照试验。

Patients with BE were randomized to 2-yearly surveillance endoscopy or "at-need" endoscopy, offered for symptoms only.

患有BE的患者被随机分配到每两年进行一次监测性内窥镜检查，或者仅在出现症状时进行“按需”内窥镜检查。

Follow-up was a minimum of 10 years.

随访时间最少为10年。

The primary outcome was overall survivalin the intention-to-treatpopulation.

主要结果是在意向治疗人群中总生存。

Secondary outcomes included cancer-specific survival, time to diagnosis of EAC, stage of EAC at diagnosis, frequency of endoscopy, and serious adverse events related to interventions.

次要结果包括癌症特异性生存率、食管腺癌诊断时间、诊断时食管腺癌的分期、内镜检查频率以及与干预措施相关的严重不良事件。

Results

There were 3453 patients recruited; 1733 patients were randomized to surveillance and 1719 to at-need endoscopy.

共有3453名患者被纳入研究；1733名患者被随机分配到监测组，1719名患者被随机分配到需要时进行内镜检查组。

Median follow-up time was 12.8 years for the primary outcome.

主要结果的中位随访时间为12.8年。

There was no evidence of a difference in overall survivalbetween the surveillance arm (333 deaths among 1733 patients) and the at-need arm (356 deaths among 1719 patients; hazard ratio, 0.95; 95% CI, 0.82-1.10; stratified log-rank P = .503).

在监测组（1733名患者中有333例死亡）和按需治疗组（1719名患者中有356例死亡；风险比，0.95；95%置信区间，0.82-1.10；分层对数秩检验P = .503）之间，总生存没有差异的证据。

There was no evidence of a difference for surveillance vs at-need endoscopy in cancer-specific survival (108 vs 106 deaths from any cancer; hazard ratio, 1.01; 95% CI, 0.77-1.33; P = .926), time to diagnosis of EAC (40 vs 31 patients had a diagnosis of EAC; hazard ratio, 1.32; 95% CI, 0.82-2.11; P = .254), or cancer stage at diagnosis.

在癌症特异性生存率（任何癌症导致的死亡分别为108例和106例；风险比，1.01；95%置信区间，0.77-1.33；P = .926）、食管腺癌诊断时间（分别有40例和31例患者被诊断为食管腺癌；风险比，1.32；95%置信区间，0.82-2.11；P = .254）或诊断时的癌症分期方面，监测性内镜检查与按需内镜检查之间没有差异。

Eight surveillance patients (0.46%) and 7 at-need patients (0.41%) reported serious adverse events.

8名监测患者（0.46%）和7名按需患者（0.41%）报告了严重不良事件。

Conclusions

Surveillance did not improve overall survivalor cancer-specific survival. At-need endoscopy may be a safe alternative for low-risk patients.

监测并未改善总生存或癌症特异性生存。对于低风险患者，按需内镜检查可能是一个安全的替代方案。

(ClinicalTrials.gov, Number: NCT00987857.).

(ClinicalTrials.gov, 编号: NCT00987857.)。