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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282563
• Other study ID #: CRAFT
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2021
• Source: Henan Cancer Hospital
• Contact: Yuzhou Zhao, Dr
• Phone: 13837126979
• Email: 13837126979[@]126.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The patients voluntarily participated in the study and signed the informed consent

2. 18 years old=75 years old

3. The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy

4. Patients scheduled for radical gastrectomy with esophagojejunostomy (also applicable for multiple primary cancers)

5. ECOG physical status score 0/1

6. ASA score I-III

7. The expected survival time is more than 12 weeks

8. The patient agreed to accept the operation and signed the informed consent form to undertake the risk of the operation

Exclusion Criteria:

1. Other malignant tumors occurred or coexisted within 5 years

2. History of upper abdominal surgery (except laparoscopic cholecystectomy)

3. History of gastric surgery (except for patients who failed ESD/EMR for gastric cancer and needed radical gastrectomy and planned esophagojejunostomy)

4. Pregnant or lactating women

5. Have a history of psychotropic drug abuse and can not quit or have mental disorders

6. Patients with severe cachexia, inability to eat or tolerate surgery

7. Preoperative imaging examination showed that the tumor invaded the surrounding organs and regional fusion enlarged lymph nodes (maximum diameter=3cm) and could not be radical resection

8. A history of unstable angina or myocardial infarction within 6 months There was a history of cerebral infarction or cerebral hemorrhage within 6 months

9. There was a history of continuous systemic corticosteroid therapy within 1 month

10. Other diseases need to be treated by surgery at the same time

11. Gastric cancer complications (bleeding, perforation, obstruction) need emergency surgery

12. Pulmonary function test FEV1<50% of predicted value

13. Patients with any severe and/or uncontrolled disease include:

1. Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure=150 mmHg, diastolic blood pressure=100 mmHg);

2. Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc=480ms) and grade 2 or above congestive heart failure (NYHA classification);

3. Active or uncontrolled severe infection (=CTCAE grade 2 infection);

4. Renal failure requires hemodialysis or peritoneal dialysis;

5. History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation;

6. The patients with poor glycemic control (FBG>10mmol/L);

7. Patients with epilepsy and need treatment;

14. According to the judgment of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

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.

Locations

Country	Name	City	State
China	Henan cancer hopital	Zhengzhou	Henan

Sponsors (6)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Henan Provincial People's Hospital, Kaifeng Central Hospital, Luoyang Central Hospital, Nanyang Central Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (7)

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Li HZ, Liu ZY, Ahmed A, Fu HQ. [Comparative observation of microcirculation and tissue healing process in gastrointestinal anastomosis with apposition or inverted suturing]. Zhonghua Wei Chang Wai Ke Za Zhi. 2011 Jan;14(1):57-60. Chinese. — View Citation

Ma PF, Cao YH, Zhang JL, Liu CY, Zhang XJ, Li S, Han GS, Zhao YZ. [Safety of two and a half layered esophagojejunal anastomosis in total gastrectomy for gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Oct 25;23(10):969-975. doi: 10.3760/cma.j.cn.441530-20191010-00445. Chinese. — View Citation

Ren JA, Li JS. [Early diagnosis and rapid treatments of gastrointestinal fistula]. Zhonghua Wei Chang Wai Ke Za Zhi. 2006 Jul;9(4):279-80. Chinese. — View Citation

Sun Y, Fang Y. [Prevention and treatment of anastomosis complications after radical gastrectomy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Feb 25;20(2):144-147. Chinese. — View Citation

Takeuchi D, Koide N, Suzuki A, Ishizone S, Shimizu F, Tsuchiya T, Kumeda S, Miyagawa S. Postoperative complications in elderly patients with gastric cancer. J Surg Res. 2015 Oct;198(2):317-26. doi: 10.1016/j.jss.2015.03.095. Epub 2015 Apr 4. — View Citation

Wang GC, Liu YJ, Cheng Y, Wang YC, Liu XY, Han GS. [Prevention of high-risk complications for high esophagojejunal anastomosis leakage after total gastrectomy]. Zhonghua Zhong Liu Za Zhi. 2017 Oct 23;39(10):792-794. doi: 10.3760/cma.j.issn.0253-3766.2017.10.014. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of complications after the operation	Criteria for determining complications: all postoperative complications were graded by Clavien?Dindo grading system. Complications of grade III and above were defined as serious complications.Judgment of anastomotic complications: (1) anastomotic leakage (2) Anastomotic bleeding (3) Anastomotic stenosis.	1 months
Primary	The incidence of operative mortality after the operation	Death after the operation	1 months
Secondary	Long term complications	Criteria for determining complications: all postoperative complications were graded by Clavien?Dindo grading system. Complications of grade III and above were defined as serious complications.Judgment of anastomotic complications: (1) anastomotic recurrence (2) Anastomotic stenosis.	One year later