Perioperative Nutritional Support in Esophageal Cancer Patients

Esophageal Cancer Clinical Trial

— NEEC  

Official title:

Perioperative Nutritional Support in Esophageal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190121
• Other study ID #: 17771
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: February 14, 2022

Study information

• Verified date: December 2019
• Source: University of Athens
• Contact: Athina-Despina Kimpizi
• Phone: 00302132088142
• Email: despinakimpizi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper GI malignancies often lead to involuntary weight loss and nutritional deficits. Nutritional support, both pre- and postoperatively, may improve post-operative course and reduce length of hospital stay. This prospective randomized trial aims to investigate the above mentioned hypothesis and clarify any variants that may differ between the investigation and control group at a statistically significant level.

Description:

This prospective randomized trial is conducted in the 1st Propaedeutic Department of Surgery of National and Kapodistrian University of Athens. The study population consists of adults suffering from upper GI malignancy. Informed consent is obtained in written. Following this, the patient is classified in either the intervention group or the control group. Patients belonging in the control group will receive the usual postoperative care, while the patients in the intervention group will receive nutritional support perioperatively. The aforementioned "usual postoperative care" consists of administration of intravenous fluids until resuming oral feeding, jejunostomy feeding starting from the first postoperative day, epidural analgesics for the first four postoperative days, perioperative administration of a second generation cephalosporin plus metronidazole and thromboprophylaxis with (low moleculr weight heparin (LMWH). The patients are also receiving appropriate for any concomitant health problems (e.g. existing diabetes mellitus) and transfusions based on their needs. We record the patient's age, the stage and histologic type of the disease, administration of adjuvant and/or neoadjuvant therapy and the patient's American Society of Anesthesiologists Score. Their preoperative nutritional state will be assessed using Body Mass Index (BMI), serum albumin, body fat percentage, muscle mass and total body water following measurement with body composition analyzer (Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer). At their initial assessment the patients will fill in an appropriate quality of life questionnaire. The type of the operation, the use of drains and catheters, the patients needs in iv fluids, blood product transfusions, sedatives and analgesics during the operation will also be recorded. The postoperative course of any patient will be closely monitored, including the postoperative needs in fluid administration and analgesics, the need for transfusion, the administration of perioperative antibiotics, the removal of drains and catheters, the time of first bowel movement,the need of ICU hospitalization, the total length of hospital stay as well as any in-hospital complications. Upon discharge from the hospital, the control group will receive instructions on oral and jejunostomy feeding, while the intervention group will receive additional nutritional support for 3 months. Both patient groups will undergo post-operative follow-up for six months. In the first, third and sixth postoperative month body weight and its change, BMI, serum albumin, body fat percentage, muscle mass and total body water, as well as quality of life, postoperative complications and need for readmission will be evaluated. Neoadjuvant therapy will also be taken into account. The results will be statistically evaluated after appropriate stratification.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with esophageal cancer

• 18 years or older

Exclusion Criteria:

-none

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Malnutrition
• Nutritional Deficiency

Intervention

Dietary Supplement:
• prosure
The study group will receive the dietary supplement preoperatively and for three months after the operation

Locations

Country	Name	City	State
Greece	Hippocration Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
THEODOROU DIMITRIOS

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient's BMI changes		first six postoperative months
Other	patient's muscle mass changes		first six postoperative months
Other	patient's body fat changes		first six postoperative months
Other	patient's serum albumin changes		first six postoperative months
Primary	infective complications	surgical site infection,pneumonia,intraabdominal sepsis,postoperative fever or other signs of sepsis	first six postoperative months
Secondary	anastomotic leak	anastomotic leak confirmed either by a CT scan or upper gastrointestinal series	first six postoperative months
Secondary	postoperative arrhythmia or other cardiac complications	cardiac complications confirmed by ECG that required consultation by a cardiologist	first six postoperative months
Secondary	readmission rate		first six postoperative months
Secondary	reoperation	need for reoperation due to postoperative complications in the first six postoperative months	first six postoperative months
Secondary	disease-associated death during the first six postoperative months	death related to the known malignancy,including postoperative complications	first six postoperative months
Secondary	length of hospital stay	postoperative duration of hospital stay	first six postoperative months (including first admission and any other readmission)
Secondary	length of stay in the ICU		first six postoperative months