Esophageal cancer
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital
Meiji Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged between 20 and 89 years old at the time of obtaining consent or day of surgery 2. Patients diagnosed with malignant tumor arising in the esophagus or esophagogastric junction, regardless of histological type 3. Patients who underwent subtotal esophagectomy based on the diagnosis in 2), regardless of preoperative treatment 4. Patients who received thoracoscopic and laparoscopic esophagectomy (including robot-assisted surgery), and who underwent one-stage gastric conduit reconstruction. Patients will be excluded if they meet any of the following apply (i) Patients who underwent two-stage surgery. (ii) Patients who underwent gastrointestinal reconstruction using grafts other than gastric conduit (such as colonic of jejunal reconstruction). (iii) Patients who were converted to thoractomy or laparotomy during surgery. (iv) Patients whose surgery was cancelled for any reason. (v) Patients who underwent jejunostomy.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of abdominal surgery accompanied with excision of gastrointestinal tract. 2. Patients with a past histroy of inflammatory bowel disease. 3. Patients whose HbA1c value was above 7.0% at the most recent outpatient visit before surgery. 4. Patients who received antibiotic treatment within one month before surgery. 5. Patients who underwent enteral nutrition of central veous nutrition within one month berfore surgery. 6. Patients who developed infectious enteritis after surgery. 7. Patients who underwent reoperation. 8. Patients who could not start enteral nutrition for any reason. 9. Patients who were deemed inappropriate by the principal investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Incidence of postoperative infectious complications (pneumonia, suture dehiscence, wound infection) of Clavien-Dindo Grade 2 or higher 2) Incidence of nausea/vomiting, abdominal distension, and diarrhea of Clavien-Dindo grade 2 or higher | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Maximum and minimum blood glucose levels from postoperative day 1 ro postoperative day 3 (POD1 to POD3) 2) Maximum daily bowel movements from POD1 to discharge 3) Maximum daily Bristol Stool Scale from POD1 to discharge 4) Measurements of blood inflammatory markers (CRP, IL-6) and intestinal barrier markers (LBP, Zonulin), and oral and fecal microbiota at three time points: preoperatively, postoperatively, and at discharge 5) Pathological findings 6) Prognosis (presence or absence of survival and recurrence, postoperative survival period and disease-free survival) | — |
Countries
Japan
Contacts
Public ContactRyoko Nozaki
National Cancer Center Hospital Department of Esophageal Surgery
Outcome results
None listed