RecruitingACTRN12616001247460

Endoscopic and histologic characterization of esophagogastric neojunction after esophagectomy


Sponsor

Instituto Portugues de Oncologia de Lisboa Francisco Gentil

Enrollment

20 participants

Start Date

Feb 23, 2016

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is following patients after esophagectomy (surgical removal of part of the oesophagus) to monitor what happens to the area where the stomach is reconnected to the remaining oesophagus. Researchers want to understand how scar-like tissue (cardiac mucosa) develops at the surgical junction, which may provide important insights into how certain types of oesophageal cancer develop. You may be eligible if: - You are between 18 and 90 years old - You have had an oesophagectomy with a stomach reconnection (gastric pull-up) procedure You may NOT be eligible if: - You have a poor general performance status (ECOG greater than 2) - You have a contraindication to having an endoscopy or sedation - You are unable to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 identi

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.


Locations(1)

Lisbon, Portugal

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ACTRN12616001247460