The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy

Официальное название

The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy：A Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn whether the application of indocyanine green near-infrared imaging system can accurately locate the recurrent laryngeal nerve (RLN) during lymph node dissection in esophageal cancer radical surgery, thereby reducing the risk of RLN injury. The main questions it aims to answer are: 1. Can preoperative intravenous administration of indocyanine green enable visualization of the RLN; 2. Does performing RLN dissection guided by near-infrared imaging system reduce the probability of RLN injury, leading to better clearance of RLN lymph nodes and improved RLN protection rates? Researchers will compare whether indocyanine green was intravenously administered preoperatively to assess intraoperative RLN visualization. Participants in the study group will receive intravenous indocyanine green at a dose of 5mg/kg 24 hours before surgery. All patients will be monitored for RLN injury-related complications postoperatively, and RLN injury status will be objectively assessed via laryngoscopy one week post-operation.

Подробное описание

Surgical treatment is currently the best and preferred method for treating esophageal cancer. Esophagectomy is a highly specialized surgery with a high incidence of complications, among which recurrent laryngeal nerve (RLN) paralysis is one of the most common postoperative complications, severely affecting postoperative quality of life. This study adopts a single-center, prospective, open, controlled, non-inferiority validation design. It focuses on patients with esophageal cancer scheduled for esophageal cancer radical surgery. The study aims to include 144 patients with esophageal cancer, randomized in a 1:1 ratio into two groups: the experimental group receiving indocyanine green (ICG) injection and the control group not receiving ICG injection. A comparison will be made between the two groups regarding laryngeal physiological changes one week post-operation. The study will observe the occurrence rate of symptoms related to RLN injury post-surgery, the duration of RLN dissection, and other relevant indicators. The goal is to explore whether the application of NIR-ICG imaging systems can accurately locate the RLN during lymph node dissection in esophageal cancer radical surgery, thereby reducing the risk of RLN injury.

Вмешательства

• Препарат ICG (Indocyanine Green)
  Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the recurrent laryngeal nerve.

Первичные конечные точки

• Incidence of Postoperative Recurrent Laryngeal Nerve Injury [Срок оценки: From enrollment to the end of surgery at 1 weeks]

Вторичные конечные точки (8)

• Rates of Temporary vs. Permanent RLN Injury [Срок оценки: Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively.]
• Incidence and Severity of Postoperative Voice Dysfunction [Срок оценки: 1 month after surgery]
• Number of Lymph Nodes Dissected in the RLN Region [Срок оценки: 1 week after surgery.]
• Incidence of Postoperative Pulmonary Complications [Срок оценки: 30 days after surgery.]
• Incidence and Severity of Postoperative Swallowing Dysfunction [Срок оценки: 30 days after surgery]
• Postoperative Hospital Stay Length [Срок оценки: 30 days after surgery.]
• Quality of Lymph Nodes Dissected in the RLN Region [Срок оценки: 1 week after surgery.]
• Postoperative Readmission Rate. [Срок оценки: 30 days after surgery.]

Критерии участия

Критерии включения

• Age between 18 and 75 years at the time of diagnosis (excluding 18 and 75);
• Preoperative biopsy pathology confirming esophageal cancer;
• Undergoing elective thoracoscopic esophageal cancer radical surgery with intraoperative anastomosis;
• Tolerable heart, lung, liver, and kidney function for surgery;
• Patients and their families are able to understand and willing to participate in this clinical study, and have signed an informed consent form.

Критерии исключения

• Allergy to ICG or iodine;
• History of neck or thoracic surgery;
• Patients requiring emergency surgery;
• Tumors involving adjacent organs necessitating combined organ resection;
• Patients with tumor recurrence or distant metastasis;
• Participation in or having participated in other clinical trials within 4 weeks prior to selection;
• History of severe mental illness;
• Pregnant or lactating women;
• Patients with other conditions deemed unsuitable for participation by the investigator;
• Intraoperative conversion to open thoracotomy.
• Patients who, after assessment or intraoperative exploration, cannot undergo the planned surgery;
• Patients who voluntarily withdraw from the study;
• Patients with concomitant non-neoplastic conditions that prevent them from continuing with the study protocol;
• Patients who, after enrollment in the study, are unable to complete it due to other reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Medical University Union Hospital — Фучжоу

Публикации

• Taniyama Y, Miyata G, Kamei T, Nakano T, Abe S, Katsura K, Sakurai T, Teshima J, Hikage M, Ohuchi N. Complications following recurrent laryngeal nerve lymph node dissection in oesophageal cancer surgery. Interact Cardiovasc Thorac Surg. 2015 Jan;20(1):41-6. doi: 10.1093/icvts/ivu336. Epub 2014 Oct 13. PMID 25312996
• Bundred JR, Hollis AC, Evans R, Hodson J, Whiting JL, Griffiths EA. Impact of postoperative complications on survival after oesophagectomy for oesophageal cancer. BJS Open. 2020 Jun;4(3):405-415. doi: 10.1002/bjs5.50264. Epub 2020 Feb 17. PMID 32064788
• Gelpke H, Grieder F, Decurtins M, Cadosch D. Recurrent laryngeal nerve monitoring during esophagectomy and mediastinal lymph node dissection. World J Surg. 2010 Oct;34(10):2379-82. doi: 10.1007/s00268-010-0692-0. PMID 20563722
• Hikage M, Kamei T, Nakano T, Abe S, Katsura K, Taniyama Y, Sakurai T, Teshima J, Ito S, Niizuma N, Okamoto H, Fukutomi T, Yamada M, Maruyama S, Ohuchi N. Impact of routine recurrent laryngeal nerve monitoring in prone esophagectomy with mediastinal lymph node dissection. Surg Endosc. 2017 Jul;31(7):2986-2996. doi: 10.1007/s00464-016-5317-8. Epub 2016 Nov 8. PMID 27826777
• Chevallay M, Jung M, Chon SH, Takeda FR, Akiyama J, Monig S. Esophageal cancer surgery: review of complications and their management. Ann N Y Acad Sci. 2020 Dec;1482(1):146-162. doi: 10.1111/nyas.14492. Epub 2020 Sep 15. PMID 32935342

Идентификаторы

NCT: NCT07406815 · NERV-ICG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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