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

NCT05282563 | Unknown DMC

• 1 other identifier: CRAFT
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastricneoplasms; gastrectomy; Esophagojejunal anastomosis; Complications

Outcome Measures

Primary Outcomes (2)

• 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

• The incidence of operative mortality after the operation

  Death after the operation

  1 months

Secondary Outcomes (1)

• Long term complications

  One year later

Study Arms (1)

The safety of esophagojejunostomy in total gastrectomy for gastric cancer

OTHER

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.Professor Zhao Yuzhou surgical team proposed double and a half layered esophagojejunal anastomosis to improve the safety of 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. In order to 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.

Procedure: double and a half layered esophagojejunal anastomosis

Interventions

double and a half layered esophagojejunal anastomosis PROCEDURE

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.

The safety of esophagojejunostomy in total gastrectomy for gastric cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients voluntarily participated in the study and signed the informed consent
• years old≤75 years old
• The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy
• Patients scheduled for radical gastrectomy with esophagojejunostomy (also applicable for multiple primary cancers)
• ECOG physical status score 0/1
• ASA score I-III
• The expected survival time is more than 12 weeks
• The patient agreed to accept the operation and signed the informed consent form to undertake the risk of the operation

You may not qualify if:

• Other malignant tumors occurred or coexisted within 5 years
• History of upper abdominal surgery (except laparoscopic cholecystectomy)
• History of gastric surgery (except for patients who failed ESD/EMR for gastric cancer and needed radical gastrectomy and planned esophagojejunostomy)
• Pregnant or lactating women
• Have a history of psychotropic drug abuse and can not quit or have mental disorders
• Patients with severe cachexia, inability to eat or tolerate surgery
• 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
• A history of unstable angina or myocardial infarction within 6 months There was a history of cerebral infarction or cerebral hemorrhage within 6 months
• There was a history of continuous systemic corticosteroid therapy within 1 month
• Other diseases need to be treated by surgery at the same time
• Gastric cancer complications (bleeding, perforation, obstruction) need emergency surgery
• Pulmonary function test FEV1\<50% of predicted value
• Patients with any severe and/or uncontrolled disease include:
• Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure≥150 mmHg, diastolic blood pressure≥100 mmHg);
• 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);

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Luoyang Central Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Kaifeng Central Hospital: collaborator

Study Sites (1)

Henan cancer hopital

Zhengzhou, Henan, 450008, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 33053992 BACKGROUND

• 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.

  PMID: 28226346 BACKGROUND

• 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.

  PMID: 26033612 BACKGROUND

• 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.

  PMID: 21271383 BACKGROUND

• 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. No abstract available. Chinese.

  PMID: 29061026 BACKGROUND

• 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. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• 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.

  PMID: 16886101 BACKGROUND

Study Officials

• Li Sen, Dr

  Affiliated Cancer Hospital of Zhengzhou University

  STUDY DIRECTOR

Central Study Contacts

Yuzhou Zhao, Dr

CONTACT

13837126979; 13837126979@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: March 16, 2022
• Study Start: July 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 16, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)