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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (ICG group) receiving VATS with near-infrared-indocyanine green fluorescence for RLN visualization | Experimental |
| |
| (Control group) receiving VATS without near-infrared-indocyanine green fluorescence for RLN visualiz | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG (Indocyanine Green) | Drug | Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the recurrent laryngeal nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Recurrent Laryngeal Nerve Injury | Definition and Significance: This is the core indicator for verifying the research hypothesis. It refers to the proportion of patients with objectively confirmed unilateral or bilateral RLN dysfunction after radical esophagectomy for esophageal cancer. The difference in this incidence between the ICG fluorescence-guided group and the conventional surgery (control) group will be compared. Assessment Method:Performed 7 days postoperatively (allowing for resolution of acute edema) by an independent otolaryngologist or speech-language pathologist blinded to the patient's group assignment, using fiberoptic laryngoscopy. Quantitative Indicators: Incidence=(Number of patients diagnosed with RLN palsy in each group / Total number of patients in that group) × 100%. | From enrollment to the end of surgery at 1 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Temporary vs. Permanent RLN Injury | Definition: Distinguishes the nature of nerve injury. Temporary injury refers to nerve function that recovers within 6 months postoperatively; permanent injury refers to function that has not recovered after 6 months. Assessment Method: Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively. Quantitative Indicators: Calculate the proportion of temporary and permanent injuries both among total injuries and among the total patient population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zheng | Contact | 15959002753 | lacustrian@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25312996 | Result | 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. | |
| 32064788 | Result |
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| Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively. |
| Incidence and Severity of Postoperative Voice Dysfunction | Definition: Assesses the functional consequences resulting from RLN injury. Assessment Method: (1) Voice Assessment: Use validated patient-reported questionnaires, such as the Voice Handicap Index-10 (VHI-10). 【Tips: The Voice Handicap Index-10 (VHI-10) has a score range of 0 to 40; a higher score indicates that voice handicap has a greater impact on daily life.】 Quantitative Indicators: (1) Proportion of patients with a VHI-10 total score ≥ 15 (indicating moderate or worse voice handicap) at a specified postoperative timepoint (e.g., 1 month). | 1 month after surgery |
| Number of Lymph Nodes Dissected in the RLN Region | Definition: Verifies whether ICG-guided nerve preservation compromises the oncological radicality of lymphadenectomy. Assessment Method: Based on the final postoperative pathological report. Quantitative Indicators: (1) Total Number of lymph nodes harvested from the bilateral RLN regions (left + right) per group. | 1 week after surgery. |
| Incidence of Postoperative Pulmonary Complications | Definition: RLN injury predisposes to aspiration and pneumonia, making this a crucial clinical safety indicator. Assessment Method: Use standardized definitions, such as the Clavien-Dindo classification or the Esophagectomy Complications Consensus Group (ECCG) definitions, to record pneumonia, respiratory failure, ARDS, etc., occurring within 30 days postoperatively. Quantitative Indicators: Proportion of patients experiencing pulmonary complications of Grade II or higher. | 30 days after surgery. |
| Incidence and Severity of Postoperative Swallowing Dysfunction | Definition: Assesses the functional consequences resulting from RLN injury. Assessment Method: (1) Swallowing Assessment: Use the M.D. Anderson Dysphagia Inventory (MDADI). 【Tips: MDADI consists of 20 items and covers four domains: global, emotional, functional, and physical. It uses a 5-point Likert scale for scoring, and both the domain scores and the total score range from 0 to 100 points. A higher score indicates better swallowing function and quality of life.】 Quantitative Indicators: (1) Inter-group comparison of MDADI total scores or subscale scores. | 30 days after surgery |
| Postoperative Hospital Stay Length | Definition: Reflects the overall recovery profile after surgery. Quantitative Indicators: (1) Postoperative Length of Stay (LOS): Number of days from surgery to meeting discharge criteria. | 30 days after surgery. |
| Quality of Lymph Nodes Dissected in the RLN Region | Definition: Verifies whether ICG-guided nerve preservation compromises the oncological radicality of lymphadenectomy. Assessment Method: Based on the final postoperative pathological report. Quantitative Indicators: (1) Metastasis Positive Rate in this region (number of metastatic lymph nodes / total number harvested). | 1 week after surgery. |
| Postoperative Readmission Rate. | Definition: Reflects the overall recovery profile after surgery. Quantitative Indicators: (1) 30-day Unplanned Readmission Rate: Particularly the rate of readmission due to pneumonia, dysphagia, or hoarseness-related issues. | 30 days after surgery. |
| 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. |
| 20563722 | Result | 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. |
| 27826777 | Result | 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. |
| 32935342 | Result | 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. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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