An interventional study of "C" Single Flap Plasty Reconstruction and Normal Reconstruction in Gastric Cancer and Reflux Esophagitis, sponsored by Daorong Wang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Daorong Wang · Not applicable, Interventional, and Treatment
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, we propose a reconstruction called the "C" Single Flap Plasty Reconstruction. This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "C" Single Flap Plasty Reconstruction in the treatment of gastric cancer.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Daorong Wang is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux.
Procedure: "C" Single Flap Plasty Reconstruction
1. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques.
Procedure: Normal Reconstruction
1. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux.
1. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques.
incidence of reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
Time frame: 6 months after surgery
incidence of anastomotic leakage
The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
Time frame: 30 days after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Mar 2025, 2 months later.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 2 months is below that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Daorong Wang