Clinical trial NCT02815150: Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients
Official title: Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of the Fourth Military Medical University
name: First Affiliated Hospital of Guangxi Medical University
First posted: 2016-06-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to assess the impact of preoperative oral carbohydrate drink on gastric emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore, investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate in elective gastric cancer surgery, providing direct evidence for clinical practice.

Detailed description: In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely applied in elective colorectal surgery. However, no direct evidence has been showed that whether it is safe to do so in gastric cancer patients who are fit for elective radical gastric resection.

This study aims to discuss the impact and safety of oral administration of 5% glucose solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study, which refers to a single-center, prospective, single blind, and randomized controlled study design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the study, who will be allocated into control or treatment group. Patients in control group follow the traditional routine of 6-8 hours preoperative fasting, while those in the treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The primary end-point is the preoperative gastric residual volume. The secondary end-points include preoperative PH of gastric fluid, assessment of perioperative psychosomatic conditions, rate of perioperative complications, level of insulin sensitivity, recovery of bowel function, and the length of hospital stay, etc.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* Histologically confirmed gastric adenocarcinoma
* Tumor of cT2-4aN0-2 in preoperative gastroscopy, endoscopic ultrasound, and/or abdominal computed tomography
* Fit for elective radical resection
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* American Society of Anesthesiology (ASA) status I to III
* Body mass index (BMI) of 17.5-27.5 kg/m2 .Patient agreed to participate this trial through informed consent.

Exclusion Criteria:

* Symptoms of pyloric obstruction
* Impaired bowel function, using drugs disturbing gastric secretion and gastric emptying
* History of gastric resection
* History of gastric cancer treatment
* History of major abdominal operation, or diffuse peritonitis
* Diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones
* Potential difficult airway as evaluated by anesthesiologist
* Pregnancy or breastfeeding were excluded in this trial .Patients would also be excluded if the following circumstances occurred: (1) failure of endotracheal intubation; (2) failure of intra-operative gastroscopy; or (3) irresectable tumor.

Primary outcomes:
measure: preoperative gastric residual volume of gastric fluid
timeFrame: 20-30 minutes before the surgery
Secondary outcomes:
measure: Preoperative PH of gastric fluid
timeFrame: 20-30 minutes before the surgery
measure: Preoperative thirsty/hungry scoring
timeFrame: 1 hour before the surgery
measure: Rate of perioperative complications
timeFrame: 7-8 days
measure: Recovery of bowel function
timeFrame: 3-7 days
measure: Perioperative insulin sensitivity
timeFrame: 8 days
measure: Length of hospital stay
timeFrame: 2-3 weeks
measure: Readmission rate within 30 days post operation
timeFrame: 1 month after surgery
measure: Reoperation rate within 30 days post operation
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Dongjie Yang
role: PRINCIPAL_INVESTIGATOR
References: