Gastrounit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital, University of Copenhagen, Køge, Denmark.
Gastrounit, Surgical Section, Køge, Denmark.
Br J Surg. 2020 May;107(6):655-661. doi: 10.1002/bjs.11510. Epub 2020 Feb 14.
Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts.
This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy.
Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001).
Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).
安全的腹腔镜胆囊切除术可能需要胆道成像，而无创荧光胆管造影术可能比对比 X 射线胆管造影术具有优势。本试验比较了荧光和 X 射线胆管造影术在显示胆囊、肝总胆管和胆总管之间关键交界处的作用。
本非劣效性、双盲 RCT 纳入了在择期腹腔镜胆囊切除术中接受 0.05mg/kg 吲哚菁绿术中荧光胆管造影术或 X 射线胆管造影术的患者。
2015 年 3 月至 2018 年 8 月，共有 120 名患者被随机分组（每组 60 名）。无脱落患者，所有患者均有 30 天随访数据。意向治疗分析中，荧光胆管造影组和 X 射线胆管造影组显示关键交界处的能力无差异（分别为 49 例/60 例和 51 例/60 例；P=0.230）。荧光胆管造影术快几分钟：中位数 2.0（0.5-5.0）分钟与 4.8（1.3-17.6）分钟（P<0.001）。
荧光胆管造影术在腹腔镜胆囊切除术中显示关键交界处被证实不劣于 X 射线胆管造影术。注册号：NCT02344654（http://www.clinicaltrials.gov）。
