Proximal Gastric AdenocarcinomaNCT06062225
Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy
A study testing Kamikawa, STJI and SOFY in people with Proximal Gastric Adenocarcinoma and Gastrectomy, run by Changzhi People's Hospital Affiliated to Changzhi Medical College.
Trial summary
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis
- What is being tested?
- Kamikawa, STJI and SOFY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-75 years old, male or female;
- Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15);
- No distant metastasis observed on preoperative chest radiograph, abdominal ultrasound or upper abdominal CT;
- ASA grade 1-3;
- Patients without contraindications to surgery;
- Patients and their families voluntarily signing the informed consent form and participating in the study;
Who cannot join
- Patients diagnosed with primary tumors or distant metastasis;
- Patients whose tumor is located in the greater curvature side of the stomach;
- Patients with coagulation dysfunction which could not be corrected;
- Patients who were diagnosed with viral hepatitis and cirrhosis;
- Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
- Patients with organ failure such as heart, lung, liver, brain, kidney failure;
Show all 9Show fewer
- Patients with ascites or cachexia preoperatively in poor general conditions;
- Patients diagnosed with immunodeficiency, immunosuppression or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
- Patients refusing to sign the informed consent of the study;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract (Kamikawa Versus Single-Tract Jejunal Interposition Versus SOFY Reconstruction) After Proximal Gastrectomy
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
Read the detailed description
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.
- Conditions
- Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis, Reflux Esophagitis, Postoperative Complications
- Being tested
- Kamikawa, STJI, SOFY
- Medical subject headings
- Esophagitis, Peptic, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KamikawaProcedure or surgery
Kamikawa reconstruction after proximal gastrectomy
STJIProcedure or surgery
Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
SOFYProcedure or surgery
SOFY reconstruction after proximal gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Kamikawa reconstruction | Experimental | Patients will be administered Kamikawa reconstruction after proximal gastrectomy. Receives: Procedure: Kamikawa |
| STJI reconstruction | Active comparator | Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy. Receives: Procedure: STJI |
| SOFY reconstruction | Active comparator | Patients will be administered SOFY reconstruction after proximal gastrectomy. Receives: Procedure: SOFY |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
Measured: 24 months after surgery
Secondary outcomes (4)
incidence of anastomotic leakage
The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
Measured: 14 days after surgery
incidence of anastomotic stenosis
The percentage (%) of patients developing anastomotic stenosis after surgery in each group.
Measured: 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.
Measured: 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.
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Gastric AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhi People's Hospital Affiliated to Changzhi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenqing Hu, Study chair, Changzhi People's Hospital Affiliated to Changzhi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062225
- Sponsor's protocol ID
- 2020TD27
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract (Kamikawa Versus Single-Tract Jejunal Interposition Versus SOFY Reconstruction) After Proximal Gastrectomy
- ClinicalTrials.gov ID
- NCT06062225
- Acronym / sponsor ID
- 2020TD27
- Conditions
- Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis, Reflux Esophagitis, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changzhi People's Hospital Affiliated to Changzhi Medical CollegeUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Oct 2023 (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.
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kamikawa reconstruction | Experimental | Procedure: KamikawaPatients will be administered Kamikawa reconstruction after proximal gastrectomy. |
| STJI reconstruction | Active comparator | Procedure: STJIPatients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy. |
| SOFY reconstruction | Active comparator | Procedure: SOFYPatients will be administered SOFY reconstruction after proximal gastrectomy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 20-75 years old, male or female;
- Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15);
- No distant metastasis observed on preoperative chest radiograph, abdominal ultrasound or upper abdominal CT;
- ASA grade 1-3;
- Patients without contraindications to surgery;
Key exclusion criteria (9 listed)
- Patients diagnosed with primary tumors or distant metastasis;
- Patients whose tumor is located in the greater curvature side of the stomach;
- Patients with coagulation dysfunction which could not be corrected;
- Patients who were diagnosed with viral hepatitis and cirrhosis;
- Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
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 |
|---|---|---|
| KamikawaKamikawa reconstruction after proximal gastrectomy | Procedure or surgery | Kamikawa reconstruction |
| STJISingle-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy | Procedure or surgery | STJI reconstruction |
| SOFYSOFY reconstruction after proximal gastrectomy | Procedure or surgery | SOFY reconstruction |
Primary outcome
incidence of reflux esophagitis
Time frame: 24 months after surgery
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
4 secondary outcomes
incidence of anastomotic leakage
Time frame: 14 days after surgery
incidence of anastomotic stenosis
Time frame: 24 months after surgery
operative time
Time frame: 1 day after surgery
intraoperative blood loss
Time frame: 1 day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Proximal Gastric Adenocarcinoma
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruiting
Neoadjuvant PD-1 Inhibitor Plus SOX Chemotherapy With or Without Short-Course Radiotherapy for Locally Advanced Upper Gastric or GEJ Adenocarcinoma
Locally Advanced Proximal Gastric or Gastroesophageal Junction Adenocarcinoma
Recruiting
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
Proximal Gastric Adenocarcinoma, Gastric Cancer
RecruitingObservational study
A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Proximal Gastric Adenocarcinoma, Reconstruction
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.
Wenqing Hu study chair
Changzhi People's Hospital Affiliated to Changzhi Medical College
Questions about this trial
What is this clinical trial studying?
A study testing Kamikawa, STJI and SOFY in people with Proximal Gastric Adenocarcinoma and Gastrectomy, run by Changzhi People's Hospital Affiliated to Changzhi Medical College.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Hu (+8613509754125, beibeihejiyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of reflux esophagitis (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.