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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03222635




Registration number
NCT03222635
Ethics application status
Date submitted
17/07/2017
Date registered
19/07/2017
Date last updated
24/07/2024

Titles & IDs
Public title
Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
Scientific title
Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.
Secondary ID [1] 0 0
NL6116501817
Universal Trial Number (UTN)
Trial acronym
PREFER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Submucosal Esophageal Adenocarcinoma 0 0
Barrett Esophagus 0 0
High-risk Mucosal Esophageal Adenocarcinoma 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic follow-up

Experimental: 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.


Treatment: Surgery: Endoscopic follow-up
Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis)
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
Overall survival (descriptive statistics in SPSS, percentages, survival analysis)
Timepoint [2] 0 0
5 years
Secondary outcome [1] 0 0
Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%))
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%))
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%))
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%))
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Quality of life during follow-up endoscopies (questionnaires)
Timepoint [5] 0 0
5 years

Eligibility
Key inclusion criteria
* Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
* Signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior history of high-risk mucosal or =T1sm.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/07/2028
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Roeselare
Country [5] 0 0
Germany
State/province [5] 0 0
Augsburg
Country [6] 0 0
Germany
State/province [6] 0 0
Duesseldorf
Country [7] 0 0
Germany
State/province [7] 0 0
Münich
Country [8] 0 0
Germany
State/province [8] 0 0
Regensburg
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amsterdam
Country [10] 0 0
Netherlands
State/province [10] 0 0
Eindhoven
Country [11] 0 0
Netherlands
State/province [11] 0 0
Groningen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Nieuwegein
Country [13] 0 0
Netherlands
State/province [13] 0 0
Nijmegen
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Netherlands
State/province [15] 0 0
The Hague
Country [16] 0 0
Netherlands
State/province [16] 0 0
Zwolle
Country [17] 0 0
Switzerland
State/province [17] 0 0
Zürich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
Amsterdam UMC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/study/NCT03222635
Trial related presentations / publications
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. Erratum In: Surg Endosc. 2016 Sep;30(9):4114. doi: 10.1007/s00464-016-5147-8.
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.
Public notes

Contacts
Principal investigator
Name 0 0
J. J. Bergman, MD, PhD
Address 0 0
Amsterdam UMC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vincent Bos, MD
Address 0 0
Country 0 0
Phone 0 0
+31204445500
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03222635