有茎性のない大きな結腸直腸ポリープの内視鏡的粘膜切除後の予防的二重熱切除と完全閉鎖：ランダム化比較試験 (ABLATION)
大きな非有茎性結腸直腸ポリープの内視鏡的粘膜切除後の予防的二重熱切除と完全閉鎖: ランダム化比較試験 - (HAPC-RCT)
Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. New techniques for LSL resection (hybrid argon plasma coagulation (h-APC) margin and base ablation) have shown a reduction in recurrence following the interventions.
We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation during EMR of large (≥20mm) colorectal LSLs will lead to lower rates of lesion recurrence compared to Snare tip soft coagulation (STSC) margin ablation.
調査の概要
状態
詳細な説明
This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomly assigned in a 1:1 ratio to undergo additional STSC margin ablation (control group and current standard of care) or h-APC ablation of the margins and base (experimental group).
Patients will be enrolled in the study before the endoscopy procedure, or in the outpatient clinic.
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure.
EMR intervention will be performed for all eligible patients with a large laterally spreading lesions (LSLs) by expert endoscopists. Only if a polyp meets inclusion criteria, the study subject will be enrolled and randomized into one of these 2 groups:
- Group 1: EMR + h-APC margin and base thermal ablation
- Group 2: EMR + STSC of the margin
The standard EMR technique will be used for the primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection will be used as per the current standard of care using a contrast agent and a lifting agent (e.g., NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot be removed by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares) or avulsive methods will be used. Randomization will be performed after resection is complete and before thermal ablation. After the complete removal of the polyp, depending on the randomization group, h-APC or STSC techniques will be used for margin and base or only margin ablation of the post-EMR defect.
If multiple large polyps are found and removed, the study polyp will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp associated scar in the follow-up colonoscopy. Polyps will be sent to the pathology lab and evaluated according to standard practice by institutional pathologists. To determine the homogeneity and depth of h-APC margin ablation in the pathology lab, some ablated margins might be resected using the standard cold snare technique.
Telephone calls after 14 days following the EMR will be conducted to assess possible adverse events that occurred within the first 14 days after EMR.
Follow-up 1: Surveillance colonoscopy occurring 6 months after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) following the intervention (h-APC) and the control (STSC) techniques.
Follow-up 2: Surveillance colonoscopy at 18 months (± 6 months) after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) at FU1.
Patients with visible recurrence at the EMR site will undergo additional resection for complete eradication of recurrence. Patients with no visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with subsequent treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of complete/incomplete eradication within 18 months after the initial EMR.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Quebec
-
Montreal、Quebec、カナダ
- 募集
- Centre Hospitalier de l'Université de Montréal
-
主任研究者：
- Daniel Von Renteln, MD
-
コンタクト：
- Julie Fleury
- 電話番号：30917 514-890-8000
- メール：julie.fleury.chum@ssss.gouv.qc.ca
-
-
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:
- adult ≥18 years old
- patients undergoing EMR for a large (≥20mm) colorectal LSL
- patients providing written and informed consent for study participation.
Exclusion Criteria:
- inflammatory bowel disease;
- non-elective colonoscopy;
- poor general health (American Society of Anesthesiologists classification >III);
- coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);
- pedunculated polyps (Paris class Ip, Isp);
- overt signs of deep submucosal invasive cancer (JNET 3);
- biopsy proven invasive carcinoma in a potential study polyp.
- Pregnant women
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：防止
- 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：Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC)
Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin and base of the polypectomy site will be performed using Hybrid Argon Plasma Coagulation (h-APC, Erbe Hybrid APC). |
The hybrid argon plasma coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows for the lifting of dysplastic epithelium, creating a cushion under the mucosa to facilitate the ablation of larger areas more thoroughly and with higher energy settings, while posing a low risk for side effects or complications.
他の名前：
|
|
アクティブコンパレータ：Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC)
Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin of the polypectomy site will be performed using Snare tip soft coagulation (STSC). |
The Snare tip soft coagulation (STSC) involves using a snare to remove polyps, while simultaneously applying soft coagulation to the surrounding tissue using a specialized tip on the snare.
他の名前：
|
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 |
|---|---|---|
|
Recurrence after colorectal EMR between the h-APC and STSC methods
時間枠：4 years
|
Lesion recurrence at first follow-up after EMR of large (≥20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by visual recurrence or pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. These will be evaluated from an intention to treat and per protocol standpoint. |
4 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse event rates after EMR with STSC or h-APC
時間枠：4 years
|
Adverse event rates after EMR of large (≥20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). These will be evaluated from an intention to treat and per protocol standpoint. |
4 years
|
|
Technical success of STSC or h-APC
時間枠：4 years
|
Technical success of STSC or h-APC defined as achieving a complete uninterrupted ring ofcircumferential margin ablation for STSC and h-APC, without crossover to complete the margin ablation, and achieving 100% surface ablation of the resection base for h-APC. |
4 years
|
|
Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC
時間枠：4 years
|
Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC |
4 years
|
|
High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period.
時間枠：4 years
|
High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period at the resection site. |
4 years
|
|
CRC occurrence during the 18-month follow-up period
時間枠：4 years
|
CRC occurrence after EMR during the 18-month follow-up period |
4 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
STSC または h-APC アブレーション時間
時間枠：4年
|
4年
|
|
|
フォローアップの損失
時間枠：4年
|
4年
|
|
|
欠陥閉鎖時間
時間枠：4年
|
4年
|
|
|
手続きにかかる費用
時間枠：4年
|
4年
|
|
|
Colonoscopies required to achieve lesion clearance after EMR with STSC or h-APC
時間枠：4 years
|
Colonoscopies required to achieve lesion clearance, defined as no histologic recurrence at the resection scar on follow-up. |
4 years
|
|
EMR procedure time
時間枠：4 years
|
EMR procedure time with STSC or h-APC |
4 years
|
|
Intestinal preservation 18 months after ablation
時間枠：4 years
|
Defined as no surgical resection performed. |
4 years
|
|
Clinically significant delayed bleeding in the proximal colon after EMR with STSC or h-APC
時間枠：14 days
|
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. Proximal defined as proximal to the splenic flexure. |
14 days
|
|
Clinically significant delayed bleeding in the distal colon after EMR with STSC or h-APC
時間枠：14 days
|
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. Distal defined as splenic flexure and distal. |
14 days
|
|
Clinically significant delayed bleeding in the entire colon after EMR with STSC or h-APC
時間枠：14 days
|
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. |
14 days
|
|
Delayed perforation after EMR with STSC or h-APC
時間枠：14 days
|
Delayed perforation defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract |
14 days
|
|
Any delayed bleeding after EMR
時間枠：14 days
|
Any delayed bleeding after EMR, defined as blood per rectum after the procedure |
14 days
|
|
Technical success for complete defect closure
時間枠：4 years
|
Defined as adequate apposition of the mucosal defect margins without visible submucosal areas >3 mm along the closure line. |
4 years
|
|
Factors associated with recurrence after colorectal EMR between the h-APC and STSC methods
時間枠：4 years
|
Lesion recurrence at first follow-up after EMR of large (≥20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. Factors such as age, sex, lesion size (20-29mm, ≥30mm; 20-39mm, ≥40mm), histology, location, difficulty (difficult defined as peri-appendiceal, on the ileocecal valve, resection previously attempted and failed by a referring endoscopist), use of epinephrine in submucosal injection, submucosal lifting solution, resection type (en bloc [i.e. in one piece] vs piecemeal), technical success, study site, endoscopist yearly EMR volume, presence of intraprocedural bleeding, utilization of adjunct resection methods, ileocecal or anus involvement, polyp histology/morphology will be evaluated. |
4 years
|
|
Factors associated with adverse event rates after EMR with STSC or h-APC
時間枠：30 days
|
Adverse event rates after EMR of large (≥20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). Factors such as age, sex, lesion size, morphology, histology, location, complete/incomplete/no defect closure, prophylactic vessel ablation, base ablation, anticoagulant use will be evaluated |
30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- HAPC-RCT
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 that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
IPD 共有時間枠
Beginning 12 months and ending 36 months following article publication.
IPD 共有アクセス基準
Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca . To gain access, data requestors will need to sign a data access agreement
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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。