Sponsor study identifier
interventional
225
6 countries
20
Study Start
July 25, 2017
Actual (reported)Primary Completion
July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2017
Actual (reported)July 19, 2017
Actual (reported)July 25, 2017
Actual (reported)July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis)
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.
5 years
Overall survival (descriptive statistics in SPSS, percentages, survival analysis)
Overall survival of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
5 years
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 by means of regular upper endoscopies and endoscopic ultrasounds
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Westmead hospital
Sydney, Australia
CUB Hôpital Erasme
Brussels, Belgium
AZ Maria Middelares Ghent
Ghent, Belgium
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.
J. J. Bergman, MD, PhD
Amsterdam UMC
R. E. Pouw, MD, PhD
Amsterdam UMC
First Submitted
July 17, 2017
First Posted
July 19, 2017
Study Start
July 25, 2017
Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%))
5 years
Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%))
5 years
Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%))
5 years
Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%))
5 years
Quality of life during follow-up endoscopies (questionnaires)
5 years
Contact the study team to confirm eligibility.
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
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.
Primary Completion
July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 25, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 24, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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