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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Zhen Li, MD
- Numer telefonu: 18560086106
- E-mail: qilulizhen@sdu.edu.cn
Kopia zapasowa kontaktu do badania
- Nazwa: Ning Zhong, MD
- Numer telefonu: 18560086096
- E-mail: zhongning@email.sdu.edu.cn
Lokalizacje studiów
-
-
Shandong
-
Jinan, Shandong, Chiny, 250012
- Qilu Hospital of Shandong University
-
Kontakt:
- Zhen Li
- Numer telefonu: 18560086106
- E-mail: qilulizhen@sdu.edu.cn
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
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 |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Recurrence rate at 12 months
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
R0 resection rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Periprocedural
|
Proportion of patients in whom the planned procedure was completed as intended. |
Periprocedural
|
|
Total treatment cost
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Zhen Li, MD, Qilu Hospital of Shandong University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
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Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
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Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 2026SDU-QILU-6
Plan dla danych uczestnika indywidualnego (IPD)
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Informacje o lekach i urządzeniach, dokumenty badawcze
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Bada produkt urządzenia regulowany przez amerykańską FDA
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