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

March 7, 2022 updated by: Henan Cancer Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: The safety of esophagojejunostomy in total gastrectomy for gastric cancer
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of complications after the operation
Time Frame: 1 months
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
Time Frame: 1 months
Death after the operation
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term complications
Time Frame: One year later
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Collaborators

The First Affiliated Hospital of Zhengzhou University
Henan Provincial People's Hospital
Luoyang Central Hospital
Nanyang Central Hospital
Kaifeng Central Hospital

Investigators

  • Study Director: Li Sen, Dr, Affiliated Cancer Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRAFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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