Background: Incisionless near-infrared fluorescent cholangiography (NIFC) is emerging as a promising tool to enhance the visualization of extrahepatic biliary structures during laparoscopic cholecystectomies. Methods: We conducted a single-blind, randomized, 2-arm trial comparing the efficacy of NIFC (n = 321) versus white light (WL) alone (n = 318) during laparoscopic cholecystectomy. Using the KARL STORZ Image1 S imaging system with OPAL1 technology for NIR/ICG imaging, we evaluated the detection rate for 7 biliary structures—cystic duct (CD), right hepatic duct (RHD), common hepatic duct, common bile duct, cystic common bile duct junction, cystic gallbladder junction (CGJ), and accessory ducts —before and after surgical dissection. Secondary calculations included multivariable analysis for predictors of structure visualization and comparing intergroup biliary duct injury rates. Results: Predissection detection rates were significantly superior in the NIFC group for all 7 biliary structures, ranging from 9.1% versus 2.9% to 66.6% versus 36.6% for the RHD and CD, respectively, with odds ratios ranging from 2.3 (95% CI 1.6–3.2) for the CGJ to 3.6 (1.6–9.3) for the RHD. After dissection, similar intergroup differences were observed for all structures except CD and CGJ, for which no differences were observed. Significant odds ratios ranged from 2.4 (1.7–3.5) for the common hepatic duct to 3.3 (1.3–10.4) for accessory ducts. Increased body mass index was associated with reduced detection of most structures in both groups, especially before dissection. Only 2 patients, both in the WL group, sustained a biliary duct injury. Conclusions: In a randomized controlled trial, NIFC was statistically superior to WL alone visualizing extrahepatic biliary structures during laparoscopic cholecystectomy. Registration number: NCT02702843

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Background Natural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience. Methods Under an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance. Results Nine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred. ConclusionThe limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.

This new procedure is feasible and safe. The main goal is control of the magnetic field, allowing enough controlled strength for retraction and sufficient triangulation for adequate exposure of the surgical field. This allows for the use of a single port through which an optic device with a working channel can perform the operation with safety. Finally, the procedure can be performed in a manner similar to the traditional laparoscopic cholecystectomy, and it also appears to be simple to learn.