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Kan betere voeding gewichts- en spierverlies bij patiënten die een slokdarmoperatie ondergaan tegengaan?


- candidate number26469
- NTR NumberNTR6326
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2017
- Secondary IDsNL57787.042.16  SPOT trial 201600361
- Public TitleKan betere voeding gewichts- en spierverlies bij patiënten die een slokdarmoperatie ondergaan tegengaan?
- Scientific TitleCan goal directed nutritional support reduce sarcopenia in surgical esophagus patients?
- ACRONYMSPOT-trial
- hypothesisA goal directed nutritional support can reduce sarcopenia in surgical esophagus patients.
- Healt Condition(s) or Problem(s) studiedOesophagectomy, Esophagectomy
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-feb-2017
- planned closingdate1-okt-2019
- Target number of participants100
- InterventionsStrict 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
- Primary outcomeSarcopenia (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
- TimepointsAt baseline, one-year after surgery for the primary outcomes. Other measurements will also be performed before surgery, and 3 and 6 months after surgery.
- Trial web sitenot applicable
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Marjo Campmans-Kuijpers
- CONTACT for SCIENTIFIC QUERIESDr. Marjo Campmans-Kuijpers
- Sponsor/Initiator University Medical Center Groningen (UMCG), Gelre ziekenhuizen
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryIn one Dutch hospital cancer patients undergoing esophagectomy will receive a goal directed nutritional support; in another Dutch hospital care as usual will be provided.
- Main changes (audit trail)
- RECORD11-jan-2017 - 28-mei-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl