Randomized clinical trial to evaluate the dose and administration time of indocyanine green in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy. - DOTIG Study

Instituto de Investigación Biomédica de Salamanca0 个研究点目标入组 200 人开始时间: 2022年3月18日最近更新: 2022年5月16日

适应症

试验速览

暂无简介。

•Age over 18 years.
•Autonomy, self-sufficiency and independence.
•Scheduled CL indication:
•- Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis.
•- Gallbladder polyps with indication for laparoscopic surgery.
•- Vesicular adenomyomatosis with indication for laparoscopic surgery.
•Indication of early LC (<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic).
•Deferred urgency LC indication.
•Understanding of information.
•Signature of the informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Age less than 18 years.
•Disability.
•Pregnancy or lactation.
•Chronic kidney disease (Stage > IIIb).
•Previous adverse reactions or allergies to VI.
•Previous adverse reactions or allergies to VI excipients.
•Adverse reactions or confirmed allergies to iodinated contrast agents.
•Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
•Urgent non-deferrable/emergent gallbladder surgery.
•Initial surgery by laparotomy.
•Previous suspicion of gallbladder carcinoma.
•Inability to understand the information needed to participate in the study.
•Rejection of inclusion within the study protocol.

发起方

Instituto de Investigación Biomédica de Salamanca