Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer

NCT01998230 | Completed Phase 3 DMC

• 1 other identifier: HenanCH
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of early oral food intake postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in patients with esophagectomy, the preference for this modality also rests on the traditional but undocumented reluctance to allow food at will. These assumed hazards of allowing normal food in the immediate postoperative period have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality. Whether early oral feeding after esophagectomy affects the incidence of life-threatening surgical complications, shortens the recovery time of bowel function and the postoperative hospital stay, improves postoperative quality of life in comparison with artificial feeding modality remains unclear. The investigators compared a routine of allowing liquid food at will from the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the first 7 postoperative days. The main endpoint is the incidence rate of complications.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; esophagectomy; oral feeding

Outcome Measures

Primary Outcomes (1)

• Postoperative complication

  postoperative complications are graded according to Clavin-Dindo grading system

  an expected average of 4 weeks

Secondary Outcomes (2)

• Quality of Life assessment

  6 months

• Length of postoperative stay

  an expected average of 2 weeks

Study Arms (2)

Early oral feeding group

EXPERIMENTAL

In this goup patients with esophagectomy are encouraged to begin the oral intake carefully and adjust according to tolerance on post operative day 1.

Dietary Supplement: early oral feeding

Delayed oral feeding group

NO INTERVENTION

In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of post operative day1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h.Esophagography was performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomosis leakage, and a full liquid diet was implemented on the following day and enteral infusion halted.

Interventions

early oral feeding DIETARY_SUPPLEMENT

In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.

Early oral feeding group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults subject to thoracolaparoscopic esophagectomy for esophageal cancer.

You may not qualify if:

• Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b). Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
• Patients with unstable situation after surgery (eg, need ventilation and ICU treatment) Patients medically unfit for surgical resection. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
• Mentally disabled. Expected life duration of less than 3 months.

Sponsors & Collaborators

• Yin Li: lead

Study Sites (1)

Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

Zhengzhou, Henan, 450003, China

Location

Related Publications (3)

• Chen X, Wang P, Leng C, Sun H, Liu X, Zhang R, Qin J, Hua X, Yu Y, Li H, Zhang J, Wu Z, Li Y. Early oral feeding after esophagectomy accelerated gut function recovery by regulating brain-gut peptide secretion. Surgery. 2022 Sep;172(3):919-925. doi: 10.1016/j.surg.2022.04.041. Epub 2022 Jul 3.

  PMID: 35794044 DERIVED

• Yang F, Li L, Mi Y, Zou L, Chu X, Sun A, Sun H, Liu X, Xu X. Effectiveness of the Tailored, Early Comprehensive Rehabilitation Program (t-ECRP) based on ERAS in improving the physical function recovery for patients following minimally invasive esophagectomy: a prospective randomized controlled trial. Support Care Cancer. 2022 Jun;30(6):5027-5036. doi: 10.1007/s00520-022-06924-8. Epub 2022 Feb 22.

  PMID: 35190895 DERIVED

• Sun HB, Li Y, Liu XB, Wang ZF, Zhang RX, Lerut T, Zheng Y, Liu SL, Chen XK. Impact of an Early Oral Feeding Protocol on Inflammatory Cytokine Changes After Esophagectomy. Ann Thorac Surg. 2019 Mar;107(3):912-920. doi: 10.1016/j.athoracsur.2018.09.048. Epub 2018 Nov 4.

  PMID: 30403976 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yin Li

  Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Henan Cancer Hospital

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 28, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

CN (1)