None listed
Conditions
Brief summary
The project proposes to evaluate the benefits and possible complications associated with PEG placement in a group of patients with esophageal cancer proposed for CRT, a group of high nutritional risk. The adoption of a new strategy may, in addition to improve patients quality of life, reduce healthcare costs by reducing the number of non-elective admissions. Informed consent is complete and explicit and the fundamental rights to voluntary participation and to not prejudice health care in case of refusal are included, as well as personal data confidentiality. The ethics committee believes that this study falls within the objectives of the Portuguese Institute of Oncology of Lisbon, so it should be approved.
Interventions
- Patients with esophagus cancer (squamous cell carcinoma and adenocarcinoma) and esophageal-gastric junction cancer, Siewert I, (adenocarcinoma) with dysphagia (grade>2) and/or weight loss (>10% normal body weight), proposed for isolated or neoadjuvant chemoradiotherapy (CRT) will be proposed for percutaneous endoscopic gastrostomy (PEG) placement on the multidisciplinary meeting, prior to the onset of therapeutic protocol (1-3 weeks before chemoradiotherapy treatment starts based on the clinical discretion of the treating gastoenterologist); - PEG will be placed by two gastroenterologists, by the pull method, with antibiotic prophylaxis with intravenous cefazoline (2g) administered immediately before procedure and at 8 and 16 hours post procedure. The patient will admitted for 24 hours at the Gastroenterology Department, post PEG placement procedure, and will start stoma enteral infusion after 6 hours and enteral bolus on the following day, if no complications have been registered; - If the esophageal tumor is stenotic, an esophageal dilation may be necessary. This procedure will be done by a gastroenterologist with more than 5 years' experience, using Savary-Gilliard"Registered Trademark" Dilator or esophageal dilatation balloon; patients with stenotic tumour will be identified prior to PEG placement procedure on basis of previous upper endoscopy report and PEG will be placed on the same day of the esophageal dilation; - After PEG insertion a peri-stoma cytology will be done by on of the gastroenterologists, with subsequent cytopathological evaluation; - The patient can keep oral diet in addition to enteral nutrition throughout the course of treatment; nutritional plan will be made by a dietitian and diet consists of food administered by bolus through the PEG with or without nutritional supplements according to the nutritional needs and degree of dysphagia; - In patients undergoing oesophagectomy, the PEG will be removed during surgery and the peri-stoma tissue will be sent for histopathological evaluation (tumor seeding); - In patients that do not undergo surgery the PEG will be removed at the end of the treatment after confirm that the patient eats the entire diet by the oral route. - Histopathological evaluation will be done by a pathologist with expertise in digestive pathology (more than 10 years' experience); - All surgical and post-surgical complications, the nutritional outcomes and any complications related to PEG will be registered. The weight will be recorded every two weeks before the start of therapy, weekly during the CRT, and after the CRT (end, after 2 weeks, after 4 weeks), and one month after surgery. All the records will be made by a nurse with more than 5 years' experience in the management of patients with gastrostomies, with the assistance of a dietitian with more than 5 years' experience on the management of oncological patients.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients with esophagus cancer (squamous cell carcinoma and adenocarcinoma) and esophageal-gastric junction cancer, Siewert I, (adenocarcinoma) with dysphagia (grade> 2) and/or weight loss (> 10% normal body weight), proposed for definitive or neoadjuvant CRT
Exclusion criteria
Contraindications for PEG placement: - patients with no ability to take care of PEG, - decompensated chronic liver disease, - presence of clinically significant ascites.