INDURG TRIAL Protocol: A Randomized Controlled Trial Using Indocyanine Green during Cholecystectomy in Acute Cholecystitis.

INTRODUCTION: Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries, and bile duct injury is one of its main complications. The use of real-time indocyanine green fluorescence cholangiography allows the identification of extrahepatic biliary structures, facilitating the procedure and reducing the risk of bile duct lesions. A better visualization of the bile duct may help to reduce the need for conversion to open surgery, and may also shorten operating time. The main objective of this study was to determine whether the use of indocyanine green is associated with a reduction in operating time in emergency cholecystectomies. Secondary outcomes are the postoperative hospital stay, the correct intraoperative visualization of the Calot's Triangle structures with the administration of indocyanine green, and the intraoperative complications, postoperative complications and morbidity according to the Clavien-Dindo classification. METHODS: This is a randomized, prospective, controlled, multicenter trial with patients diagnosed with acute cholecystitis requiring emergency cholecystectomy. The control group will comprise 220 patients undergoing emergency laparoscopic cholecystectomy applying the standard technique. The intervention group will comprise 220 patients also undergoing emergency laparoscopic cholecystectomy for acute cholecystitis with prior administration of indocyanine green. CONCLUSION: Due to the lack of published studies on ICG in emergency laparoscopic cholecystectomy, this study may help to establish procedures for its use in the emergency setting.

Results during the learning curve in the laparoscopic common bile duct exploration for choledocolithiasis.

OBJECTIVES: To analyze the results obtained in terms of efficacy and safety during the learning curve of a surgical team in the technique of laparoscopic common bile duct exploration with cholecystectomy (LCBDE+LC) using choledochoscopy for the treatment of patients with cholelithiasis and choledocolithiasis or common bile duct stones (CBDS) (CDL). METHODS: Single-center prospective analysis of patients treated with LCBDE+LC during the first 4 years of implementation of the technique. A descriptive and comparative analysis was carried out between groups according to the transcystic (TCi) or transcolecocal (TCo) approach, and also evolutionary by periods. The effectiveness of the technique was evaluated using the variable success rate and safety through the analysis of the overall complication rate and the bile leak rate as the most frequent adverse effect. RESULTS: A total of 78 patients were analyzed. The most frequent approach was TCo (62%). The overall success rate was 92%. The TCi group had a shorter operating time, a lower overall complications rate and a shorter hospital stay. The TCo approach was related to a higher rate of clinically relevant bile leak (8%). Complex cases increased significantly during the learning curve without effect on the overall results. CONCLUSIONS: LCBDE+LC is an effective and safe technique during the learning curve. Its results are comparable to those published by more experienced groups and do not present significant differences related to the evolution during learning period.