Indocyanine Green Lymphatic Mapping in Minimally Invasive Sigmoid and Rectal Cancer Surgery
Indocyanine Green Lymph Node Mapping During Minimally Invasive Rectosigmoid Cancer Surgery: A Prospective Single-Center Study
This prospective, single-center, non-randomized study with a historical control group evaluated the clinical utility of indocyanine green-guided lymphatic mapping (ICG-LM) during minimally invasive surgery for sigmoid colon and rectal cancer.
Adequate lymph node removal is an essential component of colorectal cancer surgery, as the number of lymph nodes examined influences the accuracy of pathological staging and subsequent treatment decisions. Current oncological recommendations generally support the examination of at least 12 lymph nodes for adequate nodal assessment.
Indocyanine green is a fluorescent dye that enables visualization of lymphatic drainage pathways using near-infrared imaging. Fluorescence-guided lymphatic mapping may help surgeons identify lymphatic structures and lymph nodes that are not readily visible under conventional imaging.
Patients prospectively enrolled in the intervention group underwent endoscopic submucosal injection of ICG before minimally invasive oncological resection. Intraoperative near-infrared fluorescence imaging was used to visualize lymphatic drainage and guide lymph node identification. Outcomes were compared with those of a historical control group of patients who had undergone standard minimally invasive surgery without fluorescence-guided lymphatic mapping.
The primary outcome was the adequacy of lymphadenectomy, evaluated by the proportion of patients with fewer than 12 lymph nodes retrieved and identified during histopathological examination.
Additional outcomes included the total number of retrieved lymph nodes, metastatic lymph node yield, operative time, and postoperative outcomes.
Propensity score matching and overlap weighting were used to account for differences in baseline characteristics between the intervention and historical control groups.
The study assessed the potential value of ICG-guided lymphatic mapping for improving lymph node assessment during minimally invasive surgery for sigmoid colon and rectal cancer.
調査の概要
詳細な説明
Background and Rationale
Adequate lymphadenectomy is a fundamental component of curative-intent surgery for colorectal cancer. Accurate pathological assessment of regional lymph nodes is essential for determining disease stage, guiding adjuvant treatment, and estimating prognosis. Retrieval and examination of at least 12 lymph nodes is widely accepted as a benchmark for adequate nodal staging.
Nevertheless, lymph node yield may vary according to patient characteristics, tumor location, previous neoadjuvant treatment, surgical technique, and pathological assessment.
Indocyanine green-guided lymphatic mapping (ICG-LM) is a fluorescence-guided surgical technique that enables visualization of lymphatic drainage pathways using near-infrared imaging. By identifying fluorescent lymphatic structures and lymph nodes, this approach may improve intraoperative recognition of lymphatic drainage patterns and facilitate lymph node retrieval.
Study Design and Population
This was a prospective, single-center, non-randomized comparative study with a historical control group, conducted at the University Hospital in Krakow, Poland.
The study included patients undergoing minimally invasive oncological resection for sigmoid colon or rectal adenocarcinoma.
The intervention group consisted of prospectively enrolled patients who underwent indocyanine green-guided lymphatic mapping during minimally invasive colorectal cancer surgery.
The historical control group consisted of patients who had previously undergone standard minimally invasive oncological resection without ICG-guided lymphatic mapping. Clinical and perioperative data from the historical cohort were used for comparative analysis.
No random allocation was performed.
ICG Administration and Fluorescence-Guided Surgery
Patients in the intervention group underwent intraoperative endoscopic administration of indocyanine green into the submucosal layer surrounding the tumor.
The administered dose was 2.5 mg of ICG, corresponding to 2 mL of a solution with a concentration of 1.25 mg/mL.
During minimally invasive surgery, near-infrared fluorescence imaging was used to visualize lymphatic drainage pathways and fluorescent lymph nodes.
Standard oncological resection and lymphadenectomy were performed according to established surgical principles. Fluorescence imaging served as an adjunct to conventional anatomical dissection rather than a replacement for standard oncological surgery.
The fluorescence-guided technique allowed the surgical team to assess lymphatic drainage patterns and identify potentially relevant lymph nodes.
Study Outcomes
The principal outcome of the comparative analysis was the adequacy of lymphadenectomy, assessed by the proportion of patients with an inadequate lymph node yield, defined as fewer than 12 lymph nodes retrieved and identified during histopathological examination of the surgical specimen.
Additional outcomes included total lymph node yield, the number of metastatic lymph nodes, operative time, and postoperative outcomes, including complications and recovery parameters.
The study also evaluated the technical feasibility of fluorescence-guided lymphatic mapping and the intraoperative visualization of lymphatic drainage pathways.
Statistical Analysis
Because treatment allocation was not randomized and the control group was historical, propensity score-based methods were applied to reduce the influence of differences in baseline patient characteristics.
Propensity score matching (PSM) was performed to construct comparable groups based on relevant demographic and clinical characteristics.
The primary outcome was evaluated by comparing the proportion of patients with fewer than 12 retrieved lymph nodes between the ICG-LM and control groups. Effect estimates were expressed using appropriate measures of association and 95% confidence intervals.
An additional analysis using propensity score overlap weighting was performed to assess the robustness of the findings and improve comparability between treatment groups.
Secondary outcomes were compared using statistical methods appropriate to the type and distribution of each variable.
Study Significance
This study investigated the clinical utility of indocyanine green-guided lymphatic mapping in minimally invasive oncological surgery for sigmoid colon and rectal cancer.
By comparing prospectively enrolled patients undergoing fluorescence-guided surgery with a historical control cohort, the study sought to provide preliminary evidence regarding the relationship between fluorescence-guided lymphatic mapping, adequacy of lymphadenectomy, and perioperative outcomes.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Lesser Poland Voivodeship
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Krakow、Lesser Poland Voivodeship、ポーランド、30-688
- University Hospital in Krakow (Szpital Uniwersytecki w Krakowie)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18 years or older.
- Histologically confirmed or clinically suspected primary adenocarcinoma of the sigmoid colon or rectum.
- Resectable disease (cT1-T4b, N0-3, M0), according to the AJCC TNM classification, 8th edition.
- Eligibility for curative-intent minimally invasive surgical resection (laparoscopic or robotic), either as initial treatment or following neoadjuvant therapy.
Exclusion Criteria:
- Unresectable distant metastases identified on preoperative imaging.
- Pregnancy or breastfeeding.
- Known allergy to iodine-containing compounds or previous adverse reactions to indocyanine green (ICG).
Intraoperative Exclusion Criteria:
- Intraoperative identification of unresectable metastatic disease.
- Conversion to open surgery.
- Final histopathological diagnosis inconsistent with adenocarcinoma.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intraoperative ICG-Guided Lymphatic Mapping
Patients with sigmoid colon or rectal cancer undergoing minimally invasive oncological resection with intraoperative indocyanine green (ICG)-guided lymphatic mapping. ICG was administered intraoperatively at a total dose of 2.5 mg, corresponding to 2 mL of a solution with a concentration of 1.25 mg/mL. Near-infrared fluorescence imaging was used to visualize lymphatic drainage pathways and identify fluorescent lymph nodes, including those outside the expected lymphatic drainage territory. Fluorescence findings were used to guide intraoperative assessment of lymphatic drainage and identify potential aberrant drainage pathways. |
Intraoperative lymphatic mapping using indocyanine green (ICG) during minimally invasive oncological resection for sigmoid colon or rectal cancer. Under general anesthesia, before surgical resection, ICG was administered endoscopically into the submucosal layer around the tumor using a 23-gauge injection needle introduced through the working channel of a flexible endoscope. A total of 2.5 mg of ICG (2 mL of a 1.25 mg/mL solution) was injected at four peritumoral sites (0.5 mL per site). After completion of standard oncological resection, near-infrared fluorescence imaging was used to visualize lymphatic drainage and identify fluorescent lymph nodes outside the standard dissection field. These additional lymph nodes were removed separately for histopathological examination. |
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介入なし：Historical Control Group - Standard Surgery
Patients with sigmoid colon or rectal cancer who underwent minimally invasive oncological resection without indocyanine green (ICG)-guided lymphatic mapping. This historical control group consisted of patients treated at the same institution before implementation of the ICG lymphatic mapping protocol. All patients underwent standard oncological resection with lymphadenectomy according to established surgical principles. No ICG was administered for lymphatic mapping, and no fluorescence-guided lymph node identification was performed. Data were collected retrospectively from institutional medical records for comparison with the prospectively enrolled ICG-LM group. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Patients With Inadequate Lymphadenectomy
時間枠：From surgery to final histopathological assessment (approximately 30 days after surgery).
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The proportion of patients with inadequate lymphadenectomy, defined as retrieval of fewer than 12 lymph nodes in the surgical specimen, as determined by final histopathological examination. This outcome will be compared between patients undergoing minimally invasive colorectal cancer surgery with intraoperative indocyanine green-guided lymphatic mapping (ICG-LM) and a historical control group undergoing standard minimally invasive surgery without ICG-LM. |
From surgery to final histopathological assessment (approximately 30 days after surgery).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Number of Retrieved Lymph Nodes
時間枠：From surgery to final histopathological assessment (approximately 30 days after surgery).
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The total number of lymph nodes retrieved from the surgical specimen, as determined by final histopathological examination. The number of retrieved lymph nodes will be compared between the ICG-guided lymphatic mapping group and the historical control group undergoing standard minimally invasive colorectal cancer surgery. |
From surgery to final histopathological assessment (approximately 30 days after surgery).
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Successful Lymphatic Mapping Rate
時間枠：Intraoperatively, during the index surgical procedure.
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The proportion of patients in the ICG-LM group in whom fluorescent lymphatic drainage pathways or lymph nodes were successfully visualized using near-infrared fluorescence imaging during minimally invasive colorectal cancer surgery. Mapping success will be expressed as the percentage of patients with successful visualization among all patients who received ICG. |
Intraoperatively, during the index surgical procedure.
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Aberrant Lymphatic Drainage Rate
時間枠：Intraoperatively, during the index surgical procedure.
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The proportion of patients with successfully visualized lymphatic drainage in whom ICG fluorescence imaging identified lymphatic drainage pathways outside the expected anatomical drainage territory. Aberrant drainage patterns will be assessed intraoperatively and reported as a percentage of patients with successful lymphatic mapping. |
Intraoperatively, during the index surgical procedure.
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Number of Additional Lymph Nodes Identified Through ICG Mapping
時間枠：From surgery to final histopathological assessment (approximately 30 days after surgery).
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The number of additional lymph nodes identified and retrieved based on intraoperative ICG fluorescence imaging, including lymph nodes located outside the expected lymphatic drainage territory. Retrieved lymph nodes will undergo histopathological examination to determine the presence or absence of metastatic involvement. |
From surgery to final histopathological assessment (approximately 30 days after surgery).
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Postoperative Complications
時間枠：Within 30 days after surgery.
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The incidence and severity of postoperative complications assessed using the Clavien-Dindo classification (grades I-V). Complication rates and severity will be compared between the ICG-LM group and the historical control group. |
Within 30 days after surgery.
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Length of Postoperative Hospital Stay
時間枠：From the date of surgery to hospital discharge (length of postoperative hospital stay, measured in days, on average, less than 30 days).
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The number of days from the index surgical procedure to hospital discharge, compared between the ICG-LM group and the historical control group. |
From the date of surgery to hospital discharge (length of postoperative hospital stay, measured in days, on average, less than 30 days).
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Hospital Readmission Within 30 Days
時間枠：Within 30 days after surgery.
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The proportion of patients requiring unplanned hospital readmission within 30 days after the index surgical procedure. |
Within 30 days after surgery.
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30-Day Mortality
時間枠：Within 30 days after surgery.
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The proportion of patients who died from any cause within 30 days following the index surgical procedure. |
Within 30 days after surgery.
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Reoperation Within 30 Days
時間枠：Within 30 days after surgery.
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The proportion of patients requiring an additional surgical intervention within 30 days after the index surgical procedure. |
Within 30 days after surgery.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- UJCM-ICG-LM-2023
- 1072.6120.59.2023 (その他の識別子：Jagiellonian University Bioethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data will not be made publicly available due to patient confidentiality and data protection considerations.
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