Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

Jinling Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Laparoscopic Surgery; Chemotherapy; Gastric Cancer

Treatments: Procedure: Jejunostomy; Other: Early oral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01766765

EEN-001

Details and patient eligibility

About

Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time to AC is associated with worse survival. However, most clinical trials mandate that AC is still to commence within 6 to 8 weeks after surgery consideration for malnutrition, postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube for enteral nutrition is a common component of these procedures, as a result of superior postoperative organ function, decreased infection rates, and a greater likelihood to complete AC with enteral nutritional support.

Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in reductions in total complications compared with traditional postoperative feeding practices and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube routine placement and combination with FTS is still being debated. Besides, there remains some controversy over the optimal combination of nutrients and duration and timing and routes of feed administration.

The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN) following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and minimizes time to AC when compared with FTS with early oral nutrition (EON).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary gastric cancer
• R0 resection

Exclusion criteria

• Metastatic tumor
• Locally unresectable tumor
• Previous gastric/enteral resection
• Age under 18 years or over 70 years
• Preoperative complete parenteral or enteral nutrition
• Neo-adjuvant chemotherapy
• Severe malnutrition
• Lack of the patient's consent for the trial participation, jejunostomy tube insertion or epidural analgesia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Early jejunostomy nutrition

Experimental group

Treatment:

Procedure: Jejunostomy

Early oral nutrition

Active Comparator group

Treatment:

Other: Early oral nutrition