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Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

J

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)

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

Trial contacts and locations

1

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Central trial contact

Yousheng Li, MD/PhD; Qi Mao, MD/PhD

Data sourced from clinicaltrials.gov

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