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

Surgery--Complications Clinical Trial

Official title: A Multicenter, Open, Single Arm Clinical Study on the Safety of Double and a Half Layered Esophagojejunal Anastomosis in Curative Gastrectomy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Surgical resection remain the main means for gastric cancer. How to reconstruct the digestive tract after total gastrectomy for gastric cancer is a hot topic for clinicians. Compared to jejunojejunostomy, esophagojejunostomy is difficult to operate. With the development of endoscopic technique, more and more methods of total laparoscopic esophagojejunostomy have been developed in clinic and accepted by surgeons. However, due to the requirements of laparoscopic surgery for gastric cancer staging and the high cost of total laparoscopic digestive tract reconstruction, most doctors still choose open surgery or laparoscopic assisted radical gastrectomy. Esophagojejunostomy is the main method for digestive tract reconstruction.

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 also 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. For esophagojejunostomy in surgery, most doctors believe that simple instrument anastomosis can not avoid the occurrence of anastomotic leakage, and need to strengthen the anastomotic. At the same time, anastomotic reinforcement can not completely avoid the occurrence of 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.

Professor Zhao Yuzhou surgical team proposed double and a half layered esophagojejunal anastomosis 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.

This method is simple and has no special requirements for the selection of instruments and sutures. It can be carried out in all levels of hospitals. It should be noted that simple improvement of anastomosis can not completely eliminate anastomotic complications, but still need to cooperate with surgical drainage, nutritional support and other measures to reduce the harm of postoperative anastomotic leakage. Professor Zhao Yuzhou surgical team used this method to complete more than 800 gastric cancer operations. The results showed that double and a half layered esophagojejunal anastomosis can significantly reduce the incidence of anastomotic leakage and prevent anastomotic bleeding, and without increasing the incidence of anastomotic stenosis. The results have been published in chinese Journal of gastrointestinal surgery.

In order to further verify the value of this method in gastrointestinal reconstruction of gastric cancer,Professor Zhao Yuzhou surgical team plans to carry out a multicenter, randomized controlled study throughout the province. ;

Related Conditions & MeSH terms

• Surgery--Complications

• NCT number: NCT05282563
• Study type: Interventional
• Source: Henan Cancer Hospital
• Contact: Yuzhou Zhao, Dr
• Phone: 13837126979
• Email: 13837126979@126.com
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Completion date: June 1, 2024