Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma

NCT03222635 | Recruiting DMC

• 1 other identifier: NL6116501817
• Study Type: interventional
• Target: 225
• Locations: 6 countries
• Sites: 20

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).

Conditions

Submucosal Esophageal Adenocarcinoma; Barrett Esophagus; High-risk Mucosal Esophageal Adenocarcinoma

Keywords

Barrett's esophagus; Submucosal esophageal adenocarcinoma; Endoscopic treatment; Endoscopic follow-up; High-risk mucosal esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

Endoscopic follow-up

EXPERIMENTAL

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.

Procedure: Endoscopic follow-up

Interventions

Endoscopic follow-up PROCEDURE

Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds

Endoscopic follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC: lead

Study Sites (20)

Westmead hospital

Sydney, Australia

RECRUITING

CUB Hôpital Erasme

Brussels, Belgium

RECRUITING

AZ Maria Middelares Ghent

Ghent, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

AZ Delta Roeselare

Roeselare, Belgium

RECRUITING

Universitätsklinikum Augsburg

Augsburg, Germany

RECRUITING

EVK Duesseldorf

Düsseldorf, Germany

RECRUITING

MRI TUM

Münich, Germany

ACTIVE NOT RECRUITING

Barmherzige Brüder Regensburg

Regensburg, Germany

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Radboudumc

Nijmegen, Netherlands

RECRUITING

Erasmus MC - University Medical Center

Rotterdam, Netherlands

RECRUITING

Haga Medical Center

The Hague, Netherlands

RECRUITING

Isala Clinics

Zwolle, Netherlands

RECRUITING

Hirslanden private hospital group

Zurich, Switzerland

RECRUITING

University College London Hospital

London, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 20960392 BACKGROUND

• 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.

  PMID: 27357927 BACKGROUND

• 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.

  PMID: 18785950 BACKGROUND

• 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.

  PMID: 23357492 BACKGROUND

• 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.

  PMID: 25294553 BACKGROUND

• 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.

  PMID: 35288149 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• J. J. Bergman, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• R. E. Pouw, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Bos, MD

CONTACT

+31204445500; v.bos@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastrointestinal Endoscopy

Model Details: Upon achieving the designated sample size of 141 patients of the original PREFER-trial, the enrolment of further patients diagnosed with T1b N0M0 EAC and treated endoscopically will be continued as a registration cohort (no sample size) within the same study database. 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.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: July 25, 2017
• Primary Completion (Estimated): July 25, 2028
• Study Completion (Estimated): July 25, 2028
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (8); GB (2); AU (1); CH (1); DE (4); BE (4)