Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
NCT ID: NCT03222635
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
225 participants
INTERVENTIONAL
2017-07-25
2028-07-25
Brief Summary
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Detailed Description
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Yet, no data exists on the risk of lymph node metastasis in high risk T1a EAC. The risk is assumed to be lower than for EACs invading into the submucosal layer. However, a recent retrospective analysis from our own research group shows that this risk may be higher than previously assumed (6). In this nationwide retrospective study, we analyzed lymph node metastasis rates and EAC related mortality rates concerning patients with high risk T1a, low risk T1b or high risk T1b EAC who received endoscopic treatment. The study was performed in 9 Barrett Expert Centers in the Netherlands (2008-2019). 120 patients were included in the analysis, and results showed the highest lymph node metastasis risk in the high risk T1a patient group.
Aim of this multicenter study is to prospectively evaluate the safety of endoscopic follow-up in patients treated by endoscopic resection for submucosal (T1bN0M0) and high risk mucosal (T1aN0M0) EAC.
High-resolution upper endoscopy with white-light endoscopy and narrow-band imaging supplemented with an EUS are performed every three months during the first two years after ER. After 1 year, a CT-thorax/abdomen will be performed to check for distant metastasis. During the third and fourth year of follow-up, EUS and upper endoscopy are performed every six months. From the fifth year on, EUS and upper endoscopy are performed annually.
Conditions
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Study Design
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NA
SINGLE_GROUP
The high-risk T1a group will also continue as a registration cohort, since there is no available data yet to calculate a reliable sample size with. The high-risk T1a patient group will be analysed separately from the T1b patient group.
TREATMENT
NONE
Study Groups
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Endoscopic follow-up
Patients treated with endoscopic resection (ER) for a submucosal or high-risk mucosal esophageal adenocarcinoma without lymphnode- or distant metastases (N0M0) will undergo endoscopic follow-up.
Endoscopic follow-up
Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
Interventions
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Endoscopic follow-up
Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent.
Exclusion Criteria
* Synchronous esophageal squamous cell carcinoma.
* Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.
* Tumor-positive deep resection margin (R1) in ER specimen.
* Patients unable to give signed informed consent.
18 Years
ALL
No
Sponsors
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Amsterdam UMC
OTHER
Responsible Party
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Jacques J.G.H.M. Bergman
Professor of Gastrointestinal Endoscopy
Principal Investigators
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J. J. Bergman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC
R. E. Pouw, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC
Locations
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Westmead hospital
Sydney, , Australia
CUB Hôpital Erasme
Brussels, , Belgium
AZ Maria Middelares Ghent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Delta Roeselare
Roeselare, , Belgium
Universitätsklinikum Augsburg
Augsburg, , Germany
EVK Duesseldorf
Düsseldorf, , Germany
MRI TUM
Münich, , Germany
Barmherzige Brüder Regensburg
Regensburg, , Germany
Amsterdam UMC
Amsterdam, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus MC - University Medical Center
Rotterdam, , Netherlands
Haga Medical Center
The Hague, , Netherlands
Isala Clinics
Zwolle, , Netherlands
Hirslanden private hospital group
Zurich, , Switzerland
University College London Hospital
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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M. Bourke, MD, PhD
Role: primary
Arnaud Lemmers, MD, PhD
Role: primary
P. Dewint, MD, PhD
Role: primary
R. Bisschops, MD, PhD
Role: primary
D. De Wulf, MD, PhD
Role: primary
H. Messmann
Role: primary
Horst Neuhaus
Role: primary
Oliver Pech
Role: primary
V. Bos, MD
Role: primary
E. J. Schoon, MD, PhD
Role: primary
W. B. Nagengast, MD, PhD
Role: primary
B. L. Weusten, MD, PhD
Role: primary
G. J. Bulte, MD, PhD
Role: primary
A. D. Koch, MD, PhD
Role: primary
M. Houben, MD, PhD
Role: primary
B. E. Schenk, MD, PhD
Role: primary
S. Seewald
Role: primary
R. Haidry, MD, PhD
Role: primary
J. Ortiz, MD, PhD
Role: primary
References
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Alvarez Herrero L, Pouw RE, van Vilsteren FG, ten Kate FJ, Visser M, van Berge Henegouwen MI, Weusten BL, Bergman JJ. Risk of lymph node metastasis associated with deeper invasion by early adenocarcinoma of the esophagus and cardia: study based on endoscopic resection specimens. Endoscopy. 2010 Dec;42(12):1030-6. doi: 10.1055/s-0030-1255858. Epub 2010 Oct 19.
Scholvinck D, Kunzli H, Meijer S, Seldenrijk K, van Berge Henegouwen M, Bergman J, Weusten B. Management of patients with T1b esophageal adenocarcinoma: a retrospective cohort study on patient management and risk of metastatic disease. Surg Endosc. 2016 Sep;30(9):4102-13. doi: 10.1007/s00464-016-5071-y. Epub 2016 Jun 29.
Manner H, May A, Pech O, Gossner L, Rabenstein T, Gunter E, Vieth M, Stolte M, Ell C. Early Barrett's carcinoma with "low-risk" submucosal invasion: long-term results of endoscopic resection with a curative intent. Am J Gastroenterol. 2008 Oct;103(10):2589-97. doi: 10.1111/j.1572-0241.2008.02083.x. Epub 2008 Sep 10.
Manner H, Pech O, Heldmann Y, May A, Pohl J, Behrens A, Gossner L, Stolte M, Vieth M, Ell C. Efficacy, safety, and long-term results of endoscopic treatment for early stage adenocarcinoma of the esophagus with low-risk sm1 invasion. Clin Gastroenterol Hepatol. 2013 Jun;11(6):630-5; quiz e45. doi: 10.1016/j.cgh.2012.12.040. Epub 2013 Jan 26.
Manner H, Pech O, Heldmann Y, May A, Pauthner M, Lorenz D, Fisseler-Eckhoff A, Stolte M, Vieth M, Ell C. The frequency of lymph node metastasis in early-stage adenocarcinoma of the esophagus with incipient submucosal invasion (pT1b sm1) depending on histological risk patterns. Surg Endosc. 2015 Jul;29(7):1888-96. doi: 10.1007/s00464-014-3881-3. Epub 2014 Oct 8.
Nieuwenhuis EA, van Munster SN, Meijer SL, Brosens LAA, Jansen M, Weusten BLAM, Alvarez Herrero L, Alkhalaf A, Schenk E, Schoon EJ, Curvers WL, Koch AD, van de Ven SEM, Verheij EPD, Nagengast WB, Westerhof J, Houben MHMG, Tang T, Bergman JJGHM, Pouw RE; Dutch Barrett Expert Centers. Analysis of metastases rates during follow-up after endoscopic resection of early "high-risk" esophageal adenocarcinoma. Gastrointest Endosc. 2022 Aug;96(2):237-247.e3. doi: 10.1016/j.gie.2022.03.005. Epub 2022 Mar 12.
Other Identifiers
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NL6116501817
Identifier Type: -
Identifier Source: org_study_id
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