Endoscopic and histologic characterization of esophagogastric neojunction after esophagectomy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001247460
• Date of registration: 06/09/2016
• Prospective Registration: No
• Primary sponsor: Instituto Portugues de Oncologia de Lisboa Francisco Gentil
• Public title: Endoscopic and histologic characterization of esophagogastric neojunction after esophagectomy
• Scientific title: Endoscopic and histologic characterization of esophagogastric neojunction after esophagectomy
• Date of first enrolment: 23/02/2016
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616001247460.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Portugal

Contacts

• Name: Dr Daniela Vinha Pereira

• Name: Dr Daniela Vinha Pereira

Key inclusion & exclusion criteria

Inclusion criteria: Patients with esophagogastric anastomosis after esophagectomy with gastric pull-up

Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status > 2
Upper GI endoscopy and/or sedation contraindications
Patients unable to give informed consent


Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Oesophageal (gullet)

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Esophagogastric neojunction characterization after esophagectomy;Prevalence of new cardiac epithelium after esophagectomy;
Esophagogastric neojunction characterization after esophagectomy
Prevalence of new cardiac epithelium after esophagectomy

Intervention(s)

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.

Primary Outcome(s)

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.
[3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
]

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.[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(s)

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. [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.]

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) [3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
]

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. [3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.]

To evaluate the Helicobacter pylori status.
The Helicobacter pylori status will be assessed by histological analysis of gastric biopsy samples (immunohistochemistry methods).[3 months after surgery and if cardiac type epithelium could not be identified the procedure will be repeated at, 6 and 12 months.
]

Secondary ID(s)

None

Source(s) of Monetary Support

Instituto Portugues de Oncologia de Lisboa Francisco Gentil

Ethics review

Status: Approved
Approval date:
Contact:

Ethic Comission of Instituto Portugues de Oncologia de Lisboa Francisco Gentil E.P.E.