CClinicalTrials.gg
CompletedNCT01927016FREGAT IUpdated May 14, 2026

Outcomes After Esophageal Cancer Surgery

An observational study in Esophageal Neoplasm and Esophageal Disease, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,944
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Background

  • Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the eighth most common cancer worldwide
  • The incidence is increasing rapidly
  • The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes are related to diagnosis at advanced stages.
  • Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but treatment of esophageal carcinoma remains challenging and need to be considered through a multimodal approach. However the modalities and the impact of this multimodal approach at a national level are unknown Primary objective: To identify predictors of recurrence after esophageal cancer surgery

Secondary objectives :

  • 5-year recurrence free survival
  • 5-year overall survival
  • Predictors of postoperative mortality and morbidity after surgery
  • Impact of pCR on recurrence and survival
  • Impact of neoadjuvant treatments on recurrence and survival
  • Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

Methodology : European French-speaking retrospective multicentric study Inclusion criteria: All consecutive patients operated on, for a histologically proven carcinoma of the esophagus, the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study period: The data will be collected over a 11-year period from January 2000 to December 2010. Follow up will be ascertained in May 2013.

Read the detailed description

Patients with an esophageal or junctional carcinoma (including SIewert type I and II) with surgical resection of the primary tumor inclusion date will be date of surgery all patients will be followed during 5 years after surgery or time of death

02

Conditions studied

  • Esophageal Neoplasm
  • Esophageal Disease

Keywords

  • Esophageal Neoplasm
  • Esophagus
  • Surgery
  • Outcome assessment
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 2,944 is above the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the oesophago-gastric junction

Inclusion criteria

  • All consecutive patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the esopgago-gastric junction in surgical oncology investigator centers
  • Surgery performed between 1st January 2000 and 31 December 2010

Exclusion criteria

Exclusion Criteria:

  • Siewert III cancer of the oesophago-gastric junction
  • Non surgical treatment of the esophageal cancer
  • Benign lesion
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,944 participants (actual)
Patient registry
No

Groups and cohorts

  • Esophagectomy for cancer

    Patients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction

    Procedure: Esophagectomy

Interventions

  • ProcedureEsophagectomy

    Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)

06

What researchers measure

Primary outcomes

  1. To identify predictors of recurrence after esophageal cancer surgery

    clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis

    Time frame: 30 May 2012

Secondary outcomes

  1. 5 year recurrence free survival

    events: death and recurrence at 5 years after surgery

    Time frame: 30 May 2012

  2. 5 year overall survival

    all causes for death at 5 years after surgery

    Time frame: 30 may 2012

  3. Predictors of postoperative mortality and morbidity after surgery

    30-day postoperative mortality and 30-day overall postoperative morbidity

    Time frame: 30 May 2012

  4. Impact of pCR on recurrence and survival

    pathological complete response within the tumor and nodes

    Time frame: 30 May 2012

  5. Impact of neoadjuvant treatments on recurrence and survival

    looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes

    Time frame: 30 May 2012

  6. Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

    looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes

    Time frame: 30 May 2012

07

Study locations

1 site
  • University Hospital, Lille
    Lille, 59045, France
08

References and documents

Publications

  • Mariette C, Gronnier C, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Meunier B, Collet D, Piessen G; FREGAT Working Group-FRENCH-AFC; FREGAT Working Group-FRENCH-AFC. Self-expanding covered metallic stent as a bridge to surgery in esophageal cancer: impact on oncologic outcomes. J Am Coll Surg. 2015 Mar;220(3):287-96. doi: 10.1016/j.jamcollsurg.2014.11.028. Epub 2014 Dec 12. PubMed 25617915 ↗
  • Teixeira-Farinha H, Behal H, Cailliau E, Pasquer A, Duhamel A, Thereaux J, Chalret du Rieu M, Lefevre JH, Turner K, Mantziari S, Collet D, Piessen G, Gronnier C; FREGAT Network-AFC Working Group. Impact of primary endoscopic resection on oncological outcomes after esophagectomy for cancer: a retrospective propensity score-based cohort study. Surg Endosc. 2024 Sep;38(9):5169-5177. doi: 10.1007/s00464-024-11077-2. Epub 2024 Jul 22. PubMed 39039292 ↗
  • Markar SR, Gronnier C, Duhamel A, Pasquer A, Thereaux J, Chalret du Rieu M, Lefevre JH, Turner K, Luc G, Mariette C; FREGAT Working Group-FRENCH-AFC. Significance of Microscopically Incomplete Resection Margin After Esophagectomy for Esophageal Cancer. Ann Surg. 2016 Apr;263(4):712-8. doi: 10.1097/SLA.0000000000001325. PubMed 26135681 ↗
  • Gronnier C, Trechot B, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Brigand C, Vaillant JC, Adham M, Msika S, Demartines N, El Nakadi I, Piessen G, Meunier B, Collet D, Mariette C; FREGAT Working Group-FRENCH-AFC; Luc G, Cabau M, Jougon J, Badic B, Lozach P, Cappeliez S, Lebreton G, Alves A, Flamein R, Pezet D, Pipitone F, Iuga BS, Contival N, Pappalardo E, Mantziari S, Hec F, Vanderbeken M, Tessier W, Briez N, Fredon F, Gainant A, Mathonnet M, Bigourdan JM, Mezoughi S, Ducerf C, Baulieux J, Pasquer A, Baraket O, Poncet G, Vaudoyer D, Enfer J, Villeneuve L, Glehen O, Coste T, Fabre JM, Marchal F, Frisoni R, Ayav A, Brunaud L, Bresler L, Cohen C, Aze O, Venissac N, Pop D, Mouroux J, Donici I, Prudhomme M, Felli E, Lisunfui S, Seman M, Petit GG, Karoui M, Tresallet C, Menegaux F, Hannoun L, Malgras B, Lantuas D, Pautrat K, Pocard M, Valleur P. Impact of neoadjuvant chemoradiotherapy on postoperative outcomes after esophageal cancer resection: results of a European multicenter study. Ann Surg. 2014 Nov;260(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000000955. PubMed 25379847 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01927016
Lead sponsor
University Hospital, Lille
Collaborators
French Eso-Gastric Tumors Working Group, Federation of Research in Surgery (FRENCH), AFC (Association Francophone de Chirurgie)
Responsible party
Sponsor
First posted
Aug 21, 2013
Start date
Jul 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
May 14, 2026

Study contacts

Christophe Mariette, MD, PhD
study director · University Hospital, Lille
Caroline Gronnier, MD
principal investigator · CHRU LILLE
Denis Collet, MD, PhD
principal investigator · University Hospital, Bordeaux
Bernard Meunier, MD, PhD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion