Surgery--ComplicationsNCT05282563
Clinical Study on the Safety of Double and a Half Layered Esophagojejunal Anastomosis in Curative Gastrectomy
A study testing double and a half layered esophagojejunal anastomosis in people with Surgery--Complications, run by Henan Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- double and a half layered esophagojejunal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients voluntarily participated in the study and signed the informed consent
- 18 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
Who cannot join
- 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
Show all 21Show fewer
- 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);
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
- Renal failure requires hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation;
- The patients with poor glycemic control (FBG>10mmol/L);
- Patients with epilepsy and need treatment;
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan cancer hopital
Zhengzhou, Henan, 450008
Yuzhou Zhao, 13837126979, 13837126979@126.com
Yiping Jiao, 15286820287, 18704655232@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery--Complications
- Being tested
- double and a half layered esophagojejunal anastomosis
- Keywords
- Gastricneoplasms, gastrectomy, Esophagojejunal anastomosis, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double and a half layered esophagojejunal anastomosisProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: double and a half layered esophagojejunal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 months
The incidence of operative mortality after the operation
Death after the operation
Measured: 1 months
Secondary outcomes (1)
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.
Measured: One year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Jul 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Luoyang Central Hospital, Nanyang Central Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Kaifeng Central Hospital
- Responsible party
- Sponsor
- Investigators
- Li Sen, Dr, Study director, Affiliated Cancer Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282563
- Sponsor's protocol ID
- CRAFT
- Status last verified
- May 2021
- First submitted
- 29 Nov 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33053992Sun 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.
PubMed 28226346Takeuchi 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.
PubMed 26033612Li 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.
PubMed 21271383Wang 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.
PubMed 29061026Dindo 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.
PubMed 15273542Ren 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.
PubMed 16886101
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Single Arm Clinical Study on the Safety of Double and a Half Layered Esophagojejunal Anastomosis in Curative Gastrectomy
- ClinicalTrials.gov ID
- NCT05282563
- Acronym / sponsor ID
- CRAFT
- Conditions
- Surgery--Complications
- Keywords
- Gastricneoplasms, gastrectomy, Esophagojejunal anastomosis, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Luoyang Central Hospital, Nanyang Central Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Kaifeng Central Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The safety of esophagojejunostomy in total gastrectomy for gastric cancer | Other | Procedure: double and a half layered esophagojejunal anastomosisThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patients voluntarily participated in the study and signed the informed consent
- 18 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double and a half layered esophagojejunal anastomosisAfter 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. | Procedure or surgery | The safety of esophagojejunostomy in total gastrectomy for gastric cancer |
Primary outcome
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.
The incidence of operative mortality after the operation
Time frame: 1 months
Death after the operation
1 secondary outcome
Long term complications
Time frame: One year later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 33053992Ma 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.
- Background: PubMed 28226346Sun 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.
- Background: PubMed 26033612Takeuchi 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.
- Background: PubMed 21271383Li 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.
- Background: PubMed 29061026Wang 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.
- Background: PubMed 15273542Dindo 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.
- Background: PubMed 16886101Ren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Sen, Dr study director
Affiliated Cancer Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double and a half layered esophagojejunal anastomosis in people with Surgery--Complications, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuzhou Zhao, Dr (13837126979, 13837126979@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of complications after the operation (time frame: 1 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282563, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.