Clinical trial NCT04190121: Perioperative Nutritional Support in Esophageal Cancer Patients
Official title: Perioperative Nutritional Support in Esophageal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Nutritional Deficiency
Keywords: esophageal cancer,nutritional support
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* patients with esophageal cancer
* 18 years or older

Exclusion Criteria:

-none

Primary outcomes:
measure: infective complications
timeFrame: first six postoperative months
Secondary outcomes:
measure: anastomotic leak
timeFrame: first six postoperative months
measure: postoperative arrhythmia or other cardiac complications
timeFrame: first six postoperative months
measure: readmission rate
timeFrame: first six postoperative months
measure: reoperation
timeFrame: first six postoperative months
measure: disease-associated death during the first six postoperative months
timeFrame: first six postoperative months
measure: length of hospital stay
timeFrame: first six postoperative months (including first admission and any other readmission)
measure: length of stay in the ICU
timeFrame: first six postoperative months
Other outcomes:
measure: patient's BMI changes
timeFrame: first six postoperative months
measure: patient's muscle mass changes
timeFrame: first six postoperative months
measure: patient's body fat changes
timeFrame: first six postoperative months
measure: patient's serum albumin changes
timeFrame: first six postoperative months
Locations:
city: Athens
country: Greece
facility: Hippocration Hospital
Study officials:
affiliation: Hippocration Hospital
name: Dimitrios Theodorou
role: STUDY_CHAIR
affiliation: Hippocration Hospital
name: Athina-Despina Kimpizi
role: PRINCIPAL_INVESTIGATOR
References: