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Perioperative Nutritional Support in Esophageal Cancer Patients

NCT ID: NCT04190121

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2022-02-14

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer Nutritional Deficiency

Keywords

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esophageal cancer,nutritional support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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GROUP A

Group Type EXPERIMENTAL

prosure

Intervention Type DIETARY_SUPPLEMENT

The study group will receive the dietary supplement preoperatively and for three months after the operation

GROUP B

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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prosure

The study group will receive the dietary supplement preoperatively and for three months after the operation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* patients with esophageal cancer
* 18 years or older

Exclusion Criteria

-none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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THEODOROU DIMITRIOS

OTHER

Sponsor Role lead

Responsible Party

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THEODOROU DIMITRIOS

PROFESSOR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dimitrios Theodorou

Role: STUDY_CHAIR

Hippocration Hospital

Athina-Despina Kimpizi

Role: PRINCIPAL_INVESTIGATOR

Hippocration Hospital

Locations

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Hippocration Hospital

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Athina-Despina Kimpizi

Role: CONTACT

Phone: 00302132088142

Email: [email protected]

Facility Contacts

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Athina-Despoina Kimpizi

Role: primary

Other Identifiers

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17771

Identifier Type: -

Identifier Source: org_study_id