Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Investigation of the Indications and Clinical Outcomes of Endoscopic Papillectomy Versus Surgery for Ampullary Tumors
The aim of this study is to compare the efficacy and safety of endoscopic treatment (endoscopic papillectomy [EP] with or without intraductal radiofrequency ablation [RFA]) and surgical treatment (transduodenal ampullectomy [TSA] and pancreatoduodenectomy [PD]) in patients with ampullary tumors (ampullary adenoma and early ampullary carcinoma), focusing on residual disease, recurrence, postoperative complications, and overall costs.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a multicenter, two-arm, prospective cohort study. The diagnosis of ampullary adenoma must be confirmed by biopsy.
The endoscopic treatment group receives EP; patients without intraductal extension receive EP alone, while patients with intraductal extension receive additional RFA in the same or a subsequent session. The surgical treatment group receives TSA or PD. Patients are followed up at 3, 6, and 12 months after the initial treatment, then annually for at least 5 years, with side-viewing duodenoscopy, targeted biopsy, and CT assessment. To control confounding between the two groups, propensity score matching and inverse probability of treatment weighting will be applied.
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前：Zhen Li, MD
- 電話番号：18560086106
- メール：qilulizhen@sdu.edu.cn
研究連絡先のバックアップ
- 名前：Ning Zhong, MD
- 電話番号：18560086096
- メール：zhongning@email.sdu.edu.cn
研究場所
-
-
Shandong
-
Jinan、Shandong、中国、250012
- Qilu Hospital of Shandong University
-
コンタクト：
- Zhen Li
- 電話番号：18560086106
- メール：qilulizhen@sdu.edu.cn
-
-
参加基準
適格基準
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
サンプリング方法
調査対象母集団
Adult patients with histologically confirmed ampullary adenoma or early ampullary carcinoma (Tis/T1) without invasion into the duodenal muscularis propria, staged M0/N0 by EUS , MRCP and CT , with intraductal tumor extension ≤ 20 mm on EUS, MRCP, or IDUS, undergoing endoscopic papillectomy or surgery.
説明
Inclusion Criteria:
- Patients aged ≥18 years
- Patients with histologically confirmed ampullary adenoma or early ampullary carcinoma (Tis/T1) based on endoscopic biopsy (i.e., without tumor invasion into the duodenal muscularis propria).
- Preoperative staging by endoscopic ultrasound (EUS) , magnetic resonance cholangiopancreatography (MRCP) or computed tomography (CT) showing no distant metastasis (M0) and no lymph node metastasis (N0).
- Intraductal tumor extension (ITE) ≤ 20 mm assessed by EUS, MRCP or Intraductal ultrasound (IDUS ).
- Planned to undergo EP, with or without intraductal RFA, or surgical treatment (TSA or PD).
- Patients who provide written informed consent.
Exclusion Criteria:
- Patients unable to tolerate general anesthesia or surgery.
- Ectopic duodenal papilla.
- Contraindications to endoscopic procedures (e.g., severe esophageal stenosis, gastric outlet obstruction, or other conditions precluding endoscopic access to the papilla).
- Major upper abdominal surgery or previous biliary surgery history.
- Uncorrectable coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000/μL), or inability to withhold antithrombotic (anticoagulant or antiplatelet) therapy for the planned endoscopic or surgical procedure..
- Pregnant or lactating 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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
Endoscopic treatment group
Patients undergoing EP with or without RFA. |
Endoscopic papillectomy (EP); EP combined with intraductal RFA for lesions with intraductal tumor extension. |
|
Surgical treatment group
Patients undergoing surgical treatment. |
TSA or PD |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrence rate at 12 months
時間枠：At 12 months after the initial treatment
|
Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 12-month follow-up. |
At 12 months after the initial treatment
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
R0 resection rate
時間枠：Periprocedural
|
Proportion of patients with complete resection achieved at the first endoscopic or surgical intervention and confirmed by histology (negative margins). |
Periprocedural
|
|
Procedure-related adverse event rate
時間枠：Up to 90 days after the initial treatment
|
Proportion of patients who experienced at least one adverse event attributable to the initial endoscopic or surgical procedure within 30 days after the procedure, irrespective of severity. |
Up to 90 days after the initial treatment
|
|
Recurrence rate at 6 months
時間枠：At 6 months after the initial treatment
|
Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 6-month follow-up. |
At 6 months after the initial treatment
|
|
Residual lesion rate
時間枠：Up to 3 months after the initial treatment
|
Presence of residual adenoma tissue at the next endoscopy after treatment. |
Up to 3 months after the initial treatment
|
|
Clinical success rate
時間枠：Up to 5 years after the initial treatment
|
Proportion of patients who achieved complete excision of the lesion (regardless of the number of procedures) with no histologically confirmed adenoma regrowth, no evidence of invasive cancer, and without the need for surgical resection, during follow-up up to 5 years after the initial treatment. |
Up to 5 years after the initial treatment
|
|
Endoscopic treatment failure rate
時間枠：Up to 12 months after the initial treatment
|
Inability to completely resect the lesion endoscopically (regardless of the number of procedures), histopathologically invasive malignancy, or recurrence no longer amenable to endoscopic treatment. |
Up to 12 months after the initial treatment
|
|
Total number of readmissions within 12 months
時間枠：Up to 12 months after the initial treatment
|
All readmissions due to disease-related symptoms (e.g., cholangitis, pancreatitis, obstructive jaundice) or treatment-related events (e.g., bleeding, perforation, anastomotic problems). |
Up to 12 months after the initial treatment
|
|
Technical success rate
時間枠：Periprocedural
|
Proportion of patients in whom the planned procedure was completed as intended. |
Periprocedural
|
|
Total treatment cost
時間枠：Up to 12 months after the initial treatment
|
All direct medical costs from admission to 12 months after the initial treatment (including procedure, anesthesia, hospitalization, medication, examinations, and readmission costs). |
Up to 12 months after the initial treatment
|
|
Index hospitalization length of stay
時間枠：Periprocedural
|
Number of calendar days from the date of admission for the initial treatment to the date of discharge for the initial treatment,including the day of admission |
Periprocedural
|
|
Total length of stay within 12 months
時間枠：Up to 12 months after the initial treatment
|
Total number of calendar days spent in hospital within 12 months after the initial treatment, including the index hospitalization and all readmissions due to disease-related symptoms or treatment-related events. |
Up to 12 months after the initial treatment
|
|
Postprocedural pancreatitis rate
時間枠：Up to 90 days after the initial treatment
|
Defined by two of three criteria: characteristic abdominal pain; amylase or lipase > 3× upper limit of normal; imaging features of pancreatitis; severity graded mild / moderate / severe per protocol. |
Up to 90 days after the initial treatment
|
|
Postprocedural bleeding rate
時間枠：Up to 90 days after the initial treatment
|
Proportion of patients with clinically significant post-procedural bleeding within 30 days after the procedure, defined as any of the following after achieving primary haemostasis: overt bleeding symptoms (hematemesis, melena, hematochezia, or blood aspirated via nasogastric tube); haemodynamic instability attributable to bleeding; a decrease in haemoglobin greater than 2 g/dL; or direct endoscopic evidence of bleeding from the papillectomy site. |
Up to 90 days after the initial treatment
|
|
Postprocedural perforation rate
時間枠：Up to 90 days after the initial treatment
|
Direct visualization of a transmural defect during endoscopy, or radiographic evidence of extraluminal free air on abdominal CT or plain radiograph. |
Up to 90 days after the initial treatment
|
|
Postprocedural cholangitis rate
時間枠：Up to 90 days after the initial treatment
|
New onset temperature >38 °C for more than 24 hours combined with cholestasis. Severity will be graded separately according to the TG18 severity classification (Grade I / II / III) and reported descriptively. |
Up to 90 days after the initial treatment
|
|
Cumulative recurrence rate
時間枠：Through study completion, an average of 5 years
|
Cumulative recurrence during annual follow-up up to 5 years |
Through study completion, an average of 5 years
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Zhen Li, MD、Qilu Hospital of Shandong University
出版物と役立つリンク
一般刊行物
- Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Vanbiervliet G, Strijker M, Arvanitakis M, Aelvoet A, Arnelo U, Beyna T, Busch O, Deprez PH, Kunovsky L, Larghi A, Manes G, Moss A, Napoleon B, Nayar M, Perez-Cuadrado-Robles E, Seewald S, Barthet M, van Hooft JE. Endoscopic management of ampullary tumors: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Apr;53(4):429-448. doi: 10.1055/a-1397-3198. Epub 2021 Mar 16.
- Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R, Kitano S, Inomata M, Deziel DJ, Jonas E, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):17-30. doi: 10.1002/jhbp.512. Epub 2018 Jan 5.
- Abraham NS, Barkun AN, Sauer BG, Douketis J, Laine L, Noseworthy PA, Telford JJ, Leontiadis GI. American College of Gastroenterology-Canadian Association of Gastroenterology Clinical Practice Guideline: Management of Anticoagulants and Antiplatelets During Acute Gastrointestinal Bleeding and the Periendoscopic Period. Am J Gastroenterol. 2022 Apr 1;117(4):542-558. doi: 10.14309/ajg.0000000000001627.
- Karam E, Hollenbach M, Ali EA, Auriemma F, Gulla A, Heise C, Regner S, Gaujoux S; on the Pancreas 2000 Research Group; Regimbeau JM, Kahler G, Seyfried S, Vaillant JC, De Ponthaud C, Sauvanet A, Birnbaum D, Regenet N, Truant S, Perez-Cuadrado-Robles E, Bruzzi M, Lupinacci RM, Brunel M, Belfiori G, Barbier L, Salame E, Souche FR, Schwarz L, Maggino L, Salvia R, Gagniere J, Del Chiaro M, Leung G, Hackert T, Kleemann T, Paik WH, Caca K, Dugic A, Muehldorfer S, Schumacher B, Albers D. Outcomes of rescue procedures in the management of locally recurrent ampullary tumors: A Pancreas 2000/EPC study. Surgery. 2023 May;173(5):1254-1262. doi: 10.1016/j.surg.2022.12.011. Epub 2023 Jan 13.
- Fritzsche JA, Fockens P, Barthet M, Bruno MJ, Carr-Locke DL, Costamagna G, Cote GA, Deprez PH, Giovannini M, Haber GB, Hawes RH, Hyun JJ, Itoi T, Iwasaki E, Kylanpaa L, Neuhaus H, Park JY, Reddy DN, Sakai A, Bourke MJ, Voermans RP. Expert consensus on endoscopic papillectomy using a Delphi process. Gastrointest Endosc. 2021 Oct;94(4):760-773.e18. doi: 10.1016/j.gie.2021.04.009. Epub 2021 Apr 19.
- Abe S, Sakai A, Masuda A, Miki M, Harada Y, Nagao K, Inomata N, Kohashi S, Uemura H, Masuda S, Ashina S, Gonda M, Yamakawa K, Tsujimae M, Yamada Y, Tanaka T, Kobayashi T, Nakano R, Shiomi H, Tsugawa D, Yanagimoto H, Ajiki T, Kanzawa M, Fukumoto T, Itoh T, Kodama Y. Advantage of endoscopic papillectomy for ampullary tumors as an alternative treatment for pancreatoduodenectomy. Sci Rep. 2022 Sep 7;12(1):15134. doi: 10.1038/s41598-022-19439-3.
- Hollenbach M, Heise C, Abou-Ali E, Gulla A, Auriemma F, Soares K, Leung G, Schattner MA, Jarnagin WR, Wang T, Caillol F, Giovannini M, Dahel Y, Hackert T, Paik WH, Zerbi A, Nappo G, Napoleon B, Arnelo U, Haraldsson E, Halimi A, Waldthaler A, Will U, Saadeh R, Masaryk V, van der Wiel SE, Bruno MJ, Perez-Cuadrado-Robles E, Deprez P, Sauvanet A, Bolm L, Keck T, Souche R, Fabre JM, Musquer N, Kahler G, Seyfried S, Petrone MC, Mariani A, Zaccari P, Belfiori G, Crippa S, Falconi M, Partelli S, Yilmaz B, Demir IE, Ceyhan GO, Satoi S, Regimbeau JM, Gagniere J, Repici A, Anderloni A, Vollmer C, Casciani F, Del Chiaro M, Oba A, Schulick RD, Berger A, Maggino L, Salvia R, Schemmer P, Wichmann D, Inoue Y, Dinis-Ribeiro M, Laranjo A, Libanio D, Kleemann T, Sandru V, Ilie M, Ahola R, Laukkarinen J, Schumacher B, Albers D, Curdia Goncalves T, Barbier L, Salame E, Weismuller TJ, Heling D, Alves A, Karam E, Regenet N, Dugic A, Muehldorfer S, Truant S, Caca K, Meier B, Miutescu BP, Tantau M, Birnbaum D, Miksch RC, Wedi E, Salzmann K, Bruzzi M, Lupinacci RM, David P, De Ponthaud C, Schmidt A, Regner S, Gaujoux S; ESAP study group. Endoscopic papillectomy versus surgical ampullectomy for adenomas and early cancers of the papilla: a retrospective Pancreas2000/European Pancreatic Club analysis. Gut. 2025 Feb 6;74(3):397-409. doi: 10.1136/gutjnl-2022-327996.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 2026SDU-QILU-6
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。