Clinical Study on the Safety of Double and a Half Layered Esophagojejunal Anastomosis in Curative Gastrectomy

NCT05282563 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-03-16

No results posted yet for this study

Summary

Surgical resection remain the main means for gastric cancer. With the improvement of surgical techniques and concepts, the incidence of postoperative complications gradually decreased, but esophagojejunostomy complications occur frequently. Studies have showed that the risks of esophagojejunostomy leakage related to old age, obesity, malnutrition, neoadjuvant radiotherapy and chemotherapy, and the incidence rate was 1%-16.5%. The incidence of anastomotic leakage varies greatly, which suggests that effective preventive measures can reduce the probability of anastomotic leakage. In addition to the patient factors, the technique and experience of the operator are also important to reduce anastomotic leakage.

The safety of esophagojejunostomy depends on the integrity of the anastomosis, sufficient blood supply and satisfactory tension. Early tight mucosal anastomosis and the proliferation of mucosal epithelial cells can reduce the stimulation of digestive fluid to the anastomotic wound. However, there are some problems in the operation: 1. When esophagojejunostomy is completed with tubular stapler, it is the contraposition of the plasma muscular layer of the digestive tract; 2. Because of the different diameter of esophagojejunostomy and tissue hypertrophy, the internal mucosa layer of the anastomosis is often torn or the residual tissue is embedded in the anastomosis, which affects the healing of the anastomosis.

Double and a half layered esophagojejunal anastomosis was proposed to improve the safety of anastomosis. The procedure is as follows: after the end of esophagojejunostomy, 3/0 barbed suture or absorbable suture was used. First, the anastomotic site was sutured continuously for one circle, with the suture spacing of 3-4 mm and the width of 4-5 mm. Then, the continuous horizontal mattress type seromuscular layer varus suture was used to embed the anastomotic stoma for one circle, and the suture width was 5-8 mm above and below the anastomotic stoma. After the completion of esophagojejunostomy, the full-thickness reinforcement of the anastomosis and the embedding of the seromuscular layer can ensure the complete anastomosis of the mucosal layer of the anastomosis. The embedding of the seromuscular layer can also improve the anti-pressure and anti-tension of the anastomosis, and provide a guarantee for the primary healing of the anastomosis.

Conditions

  • Surgery--Complications

Interventions

PROCEDURE

double and a half layered esophagojejunal anastomosis

After the end of esophagojejunostomy, 3/0 barbed suture or absorbable suture was used. First, the anastomotic site was sutured continuously for one circle, with the suture spacing of 3-4 mm and the width of 4-5 mm. Then, the continuous horizontal mattress type seromuscular layer varus suture was used to embed the anastomotic stoma for one circle, and the suture width was 5\~8 mm above and below the anastomotic stoma. After the completion of esophagojejunostomy, the full-thickness reinforcement of the anastomosis and the embedding of the seromuscular layer can ensure the complete anastomosis of the mucosal layer of the anastomosis. The embedding of the seromuscular layer can also improve the anti-pressure and anti-tension of the anastomosis, and provide a guarantee for the primary healing of the anastomosis.

Sponsors & Collaborators

  • Luoyang Central Hospital

    collaborator OTHER
  • Nanyang Central Hospital

    collaborator OTHER
  • Henan Provincial People's Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Kaifeng Central Hospital

    collaborator OTHER
  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Li Sen, Dr · Affiliated Cancer Hospital of Zhengzhou University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282563 on ClinicalTrials.gov