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adapted protocol with changed outcome measures, changed recruitment number, no submission to ethical board review
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It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.
We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.
We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group = standard of Care regimen: 1000ml = 1000 kCal TPN postop from day 1 until day 7. Oral feeds are started from day 5 onwards if no arguments for clinical leak (cervical anastomosis) or barium swallow is normal. Oral intake consists of regular post gastrectomy diet (building up from fluids over semi-solids to solids) with eventually added high nitrogen energy drinks. | |
| Enteral feeding | Active Comparator | Treatment group: start jejunostomy feeds from day 1, with target of 1000ml = 1000kCal (= 40cc/hour). To equilibrate energy intake during build up fase, Glucose 20% is given at a total cumulative dose taking into account the dose of j-drip, cumulative not exceeding 40cc/hr. Oral feeds are started at the same time as in the control group (reg. day 5) Jejunostomy feeds are then continued for 6 weeks together with oral intake with a continuous energy administration of 1000kCal, and then stopped. After this time, patients should be on regular full diet in both groups. If failure and step-back needed, temporary switch to Glc 20% is done to maintain fluid and calory administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral feeding | Other | Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival from day of surgery | overall survival at 5 years after esophagectomy | 5 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative weight loss | weight loss will be calculated by using age- and gender corrected BMI percentiles | 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Van Veer, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Philippe Nafteux, MD | Universitaire Ziekenhuizen KU Leuven | Study Chair |
| Willy Coosemans, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Study Chair |
| Johnny Moons, MScN | Universitaire Ziekenhuizen KU Leuven | Study Chair |
| Paul De Leyn, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Leuven | Leuven | Vl-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |