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Clinical outcome of peri-operative enteral immunonutrition for oesophago-gastric cancer

The effect of peri-operative immunonutrition for oesophago-gastric cancer surgery on antioxidant status, oxidative damage and clinical outcome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43730758
Enrollment
219
Registered
2009-02-12
Start date
2003-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophago-gastric cancer Cancer Oesophago-gastric cancer

Interventions

Patients were randomised to one of the following groups: Arm 1: enteral immune enhancing diet (IED) - This group received IED (Oxepa), seven days pre- and post-operatively. Oxepa is a complete bala

Sponsors

The Northern Oesophago-Gastric Cancer Unit (NOGCU) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients (either sex) presenting to two tertiary centres, between April 2003 to January 2007, with histologically proven oesophageal or gastric malignancy and who were suitable for subtotal oesophagectomy or total gastrectomy with curative intent were eligible for the study.

Exclusion criteria

Exclusion criteria: 1. Less than seven days time from recruitment to operation date 2. Metastatic or unresectable disease 3. Respiratory tract dysfunction (partial pressure of oxygen in arterial blood [PaO2] less than 70 mmHg) 4. Cardiac dysfunction (New York Heart Class greater than three) 5. Hepatic dysfunction (Child-Pugh score greater than B) 6. Concurrent infection 7. Pregnancy 8. Aged less than 18 years

Design outcomes

Primary

MeasureTime frame
Development of infective complications. Infective and non-infective complications were noted and graded daily up until discharge. Complications were defined as those published previously (Bozzetti, Braga et al. 2001). This was collected consistently by two full time research registrars designated to the trial.

Secondary

MeasureTime frame
Non-infective complications, mortality, duration of hospital stay and nutritional status: 1. Jejunostomy/feeding-related complications: recorded daily till discharge 2. Antibiotic usage: the duration of both prophylactic and therapeutic antibiotic usage was noted 3. Length of hospital and critical care stay 4. Mortality: both in hospital and 30 days post-operatively was recorded 5. Concentration of fatty acids in plasma 6. Nutritional status: recorded by two dieticians such as weight, BMI, triceps skin fold thickness and mid-arm muscle circumference

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026