An interventional study of Kamikawa and STJI in Proximal Gastric Adenocarcinoma, Gastrectomy and Anastomosis, sponsored by Changzhi People's Hospital Affiliated to Changzhi Medical College. Not yet recruiting. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Changzhi People's Hospital Affiliated to Changzhi Medical College · Not applicable, Interventional, and Treatment
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.
83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.
This study's planned enrollment of 180 is above the median of 135 across 60 interventional studies indexed under Esophagitis, Peptic.
Browse Esophagitis, Peptic studies →Changzhi People's Hospital Affiliated to Changzhi Medical College is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Patients will be administered Kamikawa reconstruction after proximal gastrectomy.
Procedure: Kamikawa
Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy.
Procedure: STJI
Patients will be administered SOFY reconstruction after proximal gastrectomy.
Procedure: SOFY
Kamikawa reconstruction after proximal gastrectomy
Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
SOFY reconstruction after proximal gastrectomy
incidence of reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
Time frame: 24 months after surgery
incidence of anastomotic leakage
The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
Time frame: 14 days after surgery
incidence of anastomotic stenosis
The percentage (%) of patients developing anastomotic stenosis after surgery in each group.
Time frame: 24 months after surgery
operative time
The duration, measured in minutes, spent on reconstructing the digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
Time frame: 1 day after surgery
intraoperative blood loss
The amount of blood, measured in milliliters, lost during the reconstruction of digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
Time frame: 1 day after surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Changzhi People's Hospital Affiliated to Changzhi Medical College