No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer patients undergoing an esophagectomy
Sponsors and support
Secundary
Gelre Hospital Apeldoorn
Intervention
Outcome measures
Primary outcome
Sarcopenia (muscle loss) measured by psoas muscle index by a CT-scan
Secondary outcome
• Loss of muscle mass, measured by handgrip strength; arm circumference & triceps skinfold thickness; creatinin & urea in 24-hour urine.
• Incidence of Clavien Dindo complications
• Length of hospital stay and re-admittance rate
• Survival
• Quality of Life
Background summary
In one Dutch hospital cancer patients undergoing esophagectomy will receive a goal directed nutritional support; in another Dutch hospital care as usual will be provided.
Study objective
A goal directed nutritional support can reduce sarcopenia in surgical esophagus patients.
Study design
At baseline, one-year after surgery for the primary outcomes. Other measurements will also be performed before surgery, and 3 and 6 months after surgery.
Intervention
Strict nutrtional protocol consisting of:
• One dietitian: case manager during all stages of treatment
• Use PG-SGA-questionnaire before consult
• Weekly registration of nutritional intake
• Energy needs measured by indirect colorimetry
• Proactive nutritional support
Marjo Campmans-Kuijpers
Postbus 30.001
Groningen 9700RB
The Netherlands
06-55256587
M.J.E.Campmans-Kuijpers@UMCG.nl
Marjo Campmans-Kuijpers
Postbus 30.001
Groningen 9700RB
The Netherlands
06-55256587
M.J.E.Campmans-Kuijpers@UMCG.nl
Inclusion criteria
• Patients that undergo a (minimally invasive or hybrid: laparoscopy and thoracotomy or conventional open surgery) esophagectomy for cancer with cervical or intrathoracic anastomosis
• Written informed consent
• Age > 18 years
• Histologically confirmed, previously untreated esophageal cancer
• Considered suitable for radical surgery with curative intent.
• Squamous cell carcinoma, adenocarcinoma, and undifferentiated carcinoma are included.
• Tumor location included the upper, middle, lower thirds of the esophagus and esophagogastric junction tumors, but excluded postcricoid cancers.
Exclusion criteria
• Salvage esophagectomy; after previous histologically confirmed esophageal cancer treated by ‘definitive’ radio- or radiochemotherapy
• Inability to provide written consent or inability to fill out questionnaires
• Previous or concomitant malignant disease, apart from basal-cell carcinoma
• Cervical lymph-node involvement or evidence of metastases.
• Karnofsky Performance Status < 80
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6179 |
| NTR-old | NTR6326 |
| CCMO | NL57787.042.16 |