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Trial registered on ANZCTR


Registration number
ACTRN12616001247460
Ethics application status
Approved
Date submitted
9/06/2016
Date registered
6/09/2016
Date last updated
6/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Endoscopic and histologic characterization of esophagogastric neojunction after esophagectomy
Scientific title
Endoscopic and histologic characterization of esophagogastric neojunction after esophagectomy
Secondary ID [1] 288886 0
None
Universal Trial Number (UTN)
U1111-1184-0221
Trial acronym
EHCENE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophagogastric neojunction characterization after esophagectomy 298187 0
Prevalence of new cardiac epithelium after esophagectomy 298188 0
Condition category
Condition code
Oral and Gastrointestinal 298350 298350 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 299962 299962 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants have undergone esophagecyomy and then they will perform high definition upper GI endoscopy, and biopsy protocol 3 months after surgery. If cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
Each endoscopy will take approximately 15 minutes; the procedure will be performed under deep sedation, and the biopsies will be undertaken to target suspected cardiac mucosa areas and randomly at the anastomosis (4 quadrant biopsies), 2cm above (esophagus) and 2cm below (stomach) the anastomosis.
Intervention code [1] 294980 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298560 0
To evaluate the prevalence of cardiac type epithelium in the neojunction after esophagectomy (by endoscopic and histological correlation). Histological examination will be performed on biopsy samples collected during endoscopy.
Timepoint [1] 298560 0
3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
Primary outcome [2] 298561 0
To characterize endoscopic and histologically the neojunction (composite primary outcome). The biopsy samples, collected at suspected cardiac mucosa areas and randomly at the anastomosis (4 quadrant biopsies), 2cm above (esophagus) and 2cm below (stomach) the anastomosis will be characterised by hematoxilin-eosin evaluation complemented by immunohistochemistry methods.
Timepoint [2] 298561 0
3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
Secondary outcome [1] 324584 0
To characterize the columnar epithelium phenotype - cardiac, oxintic, oxintic-cardiac and/or intestinal type epithelium - by histological analysis of eosophageal biopsy samples (hematoxilin-eosin evaluation complemented by immunohistochemistry methods)
Timepoint [1] 324584 0
3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
Secondary outcome [2] 326219 0
To evaluate the degree of inflammation.
The degree of inflammation will be assessed by histological analysis of eosophageal biopsy samples (hematoxilin-eosin evaluation), and quantified as mild, moderate or severe/ulceration.
Timepoint [2] 326219 0
3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
Secondary outcome [3] 326220 0
To evaluate the presence of gastroesophageal reflux symptoms.
A questionnaire designed to evaluate the presence and periodicity of gastroesophageal reflux symptoms will be presented for all participants.
Timepoint [3] 326220 0
In each endoscopy procedure - 3 months after surgery and if cardiac type epithelium could not be identified the procedure and the questionnaire will be repeated at, 6 and 12 months.
Secondary outcome [4] 327201 0
To evaluate the Helicobacter pylori status.
The Helicobacter pylori status will be assessed by histological analysis of gastric biopsy samples (immunohistochemistry methods).
Timepoint [4] 327201 0
3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.

Eligibility
Key inclusion criteria
Patients with esophagogastric anastomosis after esophagectomy with gastric pull-up
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Upper GI endoscopy and/or sedation contraindications
Patients unable to give informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
SPSS
T student or Wilcoxon, Chi-square or Fisher's tests. Logistic regression.

No sample size calculation was performed due the the absence of previous studies evaluating the cardiac type ephithelium in neojunctions.
We intend to include approximately 20 patients per year, which represents 50% of the esophagectomy with gastric pull-up performed in our Institution. This percentage was based on the eligibility criteria and the estimated number of patients who agree to be included.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7758 0
Portugal
State/province [1] 7758 0
Lisbon

Funding & Sponsors
Funding source category [1] 293766 0
Hospital
Name [1] 293766 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Address [1] 293766 0
Rua Professor Lima Basto,
1099-023 Lisboa
Portugal
Country [1] 293766 0
Portugal
Primary sponsor type
Hospital
Name
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Address
Rua Professor Lima Basto,
1099-023 Lisboa
Portugal
Country
Portugal
Secondary sponsor category [1] 292596 0
None
Name [1] 292596 0
None
Address [1] 292596 0
None
Country [1] 292596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294716 0
Ethic Comission of Instituto Portugues de Oncologia de Lisboa Francisco Gentil E.P.E.
Ethics committee address [1] 294716 0
Rua Prof. Lima Basto
1099-023 Lisboa
Portugal
Ethics committee country [1] 294716 0
Date submitted for ethics approval [1] 294716 0
15/12/2015
Approval date [1] 294716 0
28/01/2016
Ethics approval number [1] 294716 0

Summary
Brief summary
In the last decades the incidence of gastro-esophageal junction’s (GEJ) adenocarcinoma has increased dramatically in Western countries. Therefore, the etiopathogenesis and natural history of GEJ pathological processes’ has been subject of extensive research. The definition of cardia is a controversial topic - the nature, location, extent and even the existence of cardiac mucosa is under discussion. Some authors argue that cardia is a native structure (congenital), present from birth; others, favor a metaplastic phenomenon secondary to gastroesophageal reflux.
Regardless cardia’s nature, cardiac mucosa can be identified in other locations where its nature is clearly metaplastic: esophagus (in Barrett's esophagus/CLES – columnar lined esophageal segments) and anastomosis after esophagectomy. The esophagectomy with proximal gastric resection and esofagogastrostomy ("gastric pull-up") seems to be the ideal model to study gastric reflux effect on the remaining esophagus and metaplasia development. The presence of cardiac type mucosa in the anastomosis corroborates its acquired nature, instead of a congenital origin.
We purpose to develop a prospective, observational, single-center study to evaluate/ characterize endoscopic and histologically the gastro-esophageal neo-junction of patients undergoing esophagectomy with upper polar gastrectomy and "gastric pull-up". We aim to ascertain the possible development of the cardiac type epithelium, reproducing, "in vivo" the natural history of cardiac mucosa. Patients included will perform high definition upper GI endoscopy, and biopsy protocol, at 3, 6 and 12 months, until the columnar epithelium is identified. Additionally, we will evaluate the degree of inflammation, the Helicobacter pylori status and the phenotypic profile of metaplastic columnar epithelium. Patients will also be assessed for the presence of gastroesophageal reflux symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63726 0
Dr Joana Castela
Address 63726 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Rua Prof. Lima Basto
1099-023 Lisboa
Portugal
Country 63726 0
Portugal
Phone 63726 0
+351916844455
Fax 63726 0
Email 63726 0
joanarocastela@gmail.com
Contact person for public queries
Name 63727 0
Dr Daniela Vinha Pereira
Address 63727 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Rua Prof. Lima Basto
1099-023 Lisboa
Portugal
Country 63727 0
Portugal
Phone 63727 0
+351966229108
Fax 63727 0
Email 63727 0
danielavpereira@gmail.com
Contact person for scientific queries
Name 63728 0
Dr Daniela Vinha Pereira
Address 63728 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Rua Prof. Lima Basto
1099-023 Lisboa
Portugal
Country 63728 0
Portugal
Phone 63728 0
+351966229108
Fax 63728 0
Email 63728 0
danielavpereira@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results