Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer (MB)
The Impact of ex Vivo Intra-arterial Methylene Blue Injection on Nodal Staging Accuracy and Survival in Colorectal Cancer.
Nodal staging holds both important prognostic and predictive value at colorectal cancer. Regional lymph nodes are located close to the primary tumor in the mesocolon / mesorectum. Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging "accuracy" criteria.
In order to reach this number of lymph nodes, a precise surgical technique (total mesorectal excision or complete mesocolic excision), as well as a thorough pathological specimen work-up is needed.
The aim of the study is to investigate, if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist, hence leading to a better staging and hopefully even to a better outcome in the long run.
In 2014-2015 two surgical centers randomised resected colorectal specimens in 1:1 ratio to methylene-blue injection arm and control (no injection) arm in a total of 200 consecutive cases. Both pathologic and oncologic treatment were led regardless of the injection, reports were just routinely saved in the routine medical documentation.
This retrospective study is designed to recall patient-related, surgery-related factors, as well as pathology reports including nodal staging from the medical databases. The investigators aim to find correlation between methylene blue "staining" and lymph node yield. In addition, the investigators plan to crossmatch methylene blue injection, as a process, with long term survival of the patients.
調査の概要
詳細な説明
Background:
Colorectal Cancer is the second most common cause of death in Hungary. The most important prognostic and predictive factor of colorectal cancer is the stage of disease at the time of diagnosis. Precise staging, especially nodal staging is highly important for correct planning of oncotherapy, i.e. adjuvant chemotherapy. Nodal staging relies on the proper surgical removal of mesocolon/mesorectum belonging to the the affected colorectal segment, as well as on the thorough pathology work-up of the specimen.
Current quality standards require examination of a minimum of 12 lymph nodes in order to reliably report N0 stage.
Methylene-blue injection into the main supplying artery of the removed specimen is one of the simplest and most effective techniques described to aid pathologist in lymph node harvesting.
Technique of methylene blue injection:
First of all, surgeon need to en block remove the affected colorectal segment with its mesecolon/mesorectum. Then the surgeon isolates the main supplying artery and cannulated it with an appropriate-size canula.
Methylene blue solution (50 mg methylene blue diluted in in 30 ml saline) is prepared and injected into the freshly removed specimen via the canula until the blue solution appears on the cut edges of the specimen.
The specimen can be processed in a routine way (placed in 4% formaldehyde).
Aim of the study:
The aim is to investigate if the well described and in Western-European healthcare systems well tested technique (Methylene blue injection) can be effectively adapted in an overwhelmed, busy Eastern-European healthcare environment. (Other techniques, including pathology assistant are not affordable in this area.) Apart form testing diagnostic accuracy of the pathologist on specimens with and without methylene blue injection, the investigators would like to assess a potential survival benefit of the suspected improvement of staging effectivity.
Timing of the study:
Over a 20-month period of 2014 and 2015 two surgical centers in Hungary randomised their elective colorectal resection cases into interventional and control arms. Randomisation was performed with a 1:1 ratio at each site on 100-100 consecutive cases.
Further pathology work-up and reporting has been routinely performed without any specific effect on oncology follow-up or treatment. No specific data collection has been performed after the intervention.
This study aims to retrospectively select the 100-100 (total of 200) consecutive colorectal resection cases of the given time frame from the official hospital medical recording systems.
Pathology reports and other relevant patient clinical records will be collected and statistically assessed.
Ethical approval was requested and gained from the Medical Research Council, Hungary, for the retrospective analysis of patient data.
Statistical analysis:
Power analysis was performed to get the sufficient number of cases (200 cases in total).
Case Report Form The retrospectively included cases will be listed in a specific database on a safe medical server. Anthropometric, disease-specific, operation-specific and pathology report details will be extracted out of the official patient documentation system.
Patients will be included according to the known interventional interval and the operation type (elective colorectal resection). Cases in the database will be anonymized. No patient-identifying data will be recorded or given to the assessor of the study (statistician).
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Balazs Banky, PhD
- 電話番号:36208231642
- メール:bankybalazs@gmail.com
研究連絡先のバックアップ
- 名前:Nora Susztak, MD
- 電話番号:36307283224
- メール:n.susztak@gmail.com
研究場所
-
-
-
Tatabánya、ハンガリー、2800
- St. Borbala Hospital
-
-
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:
- Elective operation.
- Colon or rectum resection performed.
- Malignant colorectal condition.
- Curative intent.
Exclusion Criteria:
- Acute surgery performed
- Final histology: benign
- No other pathologic method (apart form Methylene Blue injection) used to improve lymph node yield
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:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Methylene blue
Methylene blue solution (50 mg in 30 ml of saline solution) was injected in the cannulated main supplying artery of the freshly removed specimen, ex vivo.
Colorectal specimen was then processed in the routine pathological work-up way.
|
Methylene blue solution is injected ex vivo in the main supplying artery trunk of the freshly removed colorectal specimen.
(50 mg in 30 ml saline)
|
介入なし:Control
Colorectal specimens were processed in the routine pathological work-up way.
|
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 |
---|---|---|
Total number of lymph nodes
時間枠:Within 4 weeks after operation (at pathology work-up)
|
Total number of lymph nodes examined by pathologist
|
Within 4 weeks after operation (at pathology work-up)
|
Positive lymph nodes
時間枠:Within 4 weeks after operation (at pathology work-up)
|
Number of positive lymph nodes found by pathologist
|
Within 4 weeks after operation (at pathology work-up)
|
Nodal staging accuracy
時間枠:Within 4 weeks after operation (at pathology work-up)
|
Minimum Nr of 12 lymph nodes examined if reported N stage is N0, or positive lymph node=s) found
|
Within 4 weeks after operation (at pathology work-up)
|
At least 12 lymph nodes harvested
時間枠:Within 4 weeks after operation (at pathology work-up)
|
Minimum Nr of 12 lymph nodes examined by pathologist
|
Within 4 weeks after operation (at pathology work-up)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall survival
時間枠:5 years (60 months) after operation
|
Overall survival after operation (in months)
|
5 years (60 months) after operation
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Balazs Banky, PhD、St. Borbala Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- IV/3228/2021-EKU
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
大腸がんの臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Methylene blue injectionの臨床試験
-
Zimmer Biomet終了しました関節包内大腿骨近位骨折 | ガーデン グレード I 大腿骨頚部下骨折 | ガーデン グレード II 大腿骨頚部下骨折アメリカ
-
Hospital Universitari de Bellvitge募集
-
University of OxfordBritish Heart Foundation積極的、募集していない
-
Mohamed Sayed Mohamed Abbas完了機械的人工呼吸に依存する ICU 患者 : ICU で換気された離乳不能患者の中で経皮的気管切開を行う最も安全なモード