Gastric CancerNCT07080879
The Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Radical Gastrectomy of Distal Gastric Cancer
A study testing Linear Anastomat and Tubular Anastomat in people with Gastric Cancer, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this clinical trial is to observe and compare the short-term complications, long-term survival and quality of life of linear anastomat and tubular anastomat during digestive tract reconstruction after resection of distal gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Linear Anastomat and Tubular Anastomat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≤ 18 years old ≤75 years old;
- The primary gastric lesions were diagnosed as gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma, and poorly differentiated adenocarcinoma por) by gastroscopic biopsy.
- The patient was clinically diagnosed with gastric cancer (in line with clinical signs of gastrointestinal reconstruction after distal subtotal gastrectomy for gastric cancer);
- Implantation metastasis without peritoneum (confirmed by laparoscopic exploratory surgery);
- It is estimated that R0 results can be obtained after D2 radical resection of distal gastric cancer (also applicable for multiple primary lower cancers);
- Karnofsky score ≥60 points;
- Preoperative ASA score: I, II, or III; 8。 Routine blood examination (no transfusion within the past 14 days) : HB≥90g/L;ANC ≥1.5×109/L;PLT ≥80×109/L；
- 9. Blood biochemical examination: BIL <1.5 times the upper limit of normal value (ULN);ALT and AST<2.5× ULN;Crea≤1 x ULN.
Who cannot join
- Previous history of upper abdominal surgery (including gastric ESD/EMR, except laparoscopic cholecystectomy);
- History of acute pancreatitis;
- Preoperative imaging examination indicated fusion of enlarged lymph nodes (maximum diameter >3cm);
- Gastric cancer patients who have received neoadjuvant therapy;
- History of other malignant diseases within the past 5 years;
- History of unstable angina pectoris, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
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- History of continuous systemic corticosteroid therapy in the past 1 month;
- Concurrent surgical treatment for other diseases is required;
- Patients with gastric cancer complications (bleeding, perforation) requiring emergency surgery;
- Pyloric obstruction;
- Lung function test FEV1< 50% of the expected value;
- Pregnant or lactating women;
- Suffers from severe mental illness;
- Participate in other clinical studies at the same time;
- Refused to sign the first round of study informed consent;
- Unable or unwilling to comply with research requirements;
- Patients with PD after neoadjuvant chemotherapy and unable to undergo distal gastrectomy;
- Patients undergoing emergency surgery due to tumor bleeding, perforation and obstruction during chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on the Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Gastrointestinal Anastomosis During Radical Gastrectomy for Distal Gastric Cancer
The goal of this clinical trial is to observe and compare the short-term complications, long-term survival and quality of life of linear anastomat and tubular anastomat during digestive tract reconstruction after resection of distal gastric cancer.
Participants will receive a linear anastomat or tubular anastomat for digestive tract reconstruction during distal gastrectomy gastroenterostomy.
- Conditions
- Gastric Cancer
- Being tested
- Linear Anastomat, Tubular Anastomat
- Keywords
- Linear Anastomat and Tubular Anastomat, Distal radical gastrectomy, Gastroenterostomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear AnastomatDevice
The product registration certificate numbers of linear anastomat is Su Wei registered 20202021581.
Tubular AnastomatDevice
The product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305.
| Study group | Role | What they receive |
|---|---|---|
| Linear Anastomat Group (L Group) | Experimental | The duodenum and distal stomach were separated by linear anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the linear anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the linear anastomat. Receives: Device: Linear Anastomat |
| Tubular Anastomat Group (C Group) | Active comparator | The duodenum and distal stomach were separated by tubular anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the tubular anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the tubular anastomat. Receives: Device: Tubular Anastomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intraoperative Splenic Laceration
The number and percentage of participants experiencing splenic laceration during surgery.
Measured: Perioperative period
Incidence of Positive Incisal Margin
The number and percentage of participants with a positive incisal margin after tumor resection.
Measured: Perioperative period
Incidence of Anastomosis Failure
The number and percentage of participants experiencing anastomosis failure during surgery.
Measured: Perioperative period
Secondary outcomes (6)
Change in Procalcitonin Levels
The mean and standard deviation of procalcitonin (pg/mL or ng/mL) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).
Measured: Perioperative period
Change in C-Reactive Protein Levels
The mean and standard deviation of C-reactive protein (mg/L) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).
Measured: Perioperative period
Change in TNF-α Levels
The mean and standard deviation of TNF-α (pg/mL) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).
Measured: Perioperative period
Change in Interleukin-6 Levels
The mean and standard deviation of the percentage of CD3+, CD4+, CD8+, and NK cells among total lymphocytes, measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).
Measured: Perioperative period
Health-Related Quality of Life assessed by EORTC QLQ-C30 Overall Score
The mean and standard deviation of the overall global health status/quality of life score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), ranging from 0 to 100, with higher scores indicating better quality of life.
Measured: 3 years
Disease-Specific Quality of Life assessed by EORTC QLQ-STO22 Score
The mean and standard deviation of relevant symptom scales and functional scales from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module (EORTC QLQ-STO22).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jun 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080879
- Sponsor's protocol ID
- STAPLER01
- Status last verified
- Mar 2025
- First submitted
- 9 Apr 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Gastrointestinal Anastomosis During Radical Gastrectomy for Distal Gastric Cancer
- ClinicalTrials.gov ID
- NCT07080879
- Acronym / sponsor ID
- STAPLER01
- Conditions
- Gastric Cancer
- Keywords
- Linear Anastomat and Tubular Anastomat, Distal radical gastrectomy, Gastroenterostomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (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 goal of this clinical trial is to observe and compare the short-term complications, long-term survival and quality of life of linear anastomat and tubular anastomat during digestive tract reconstruction after resection of distal gastric cancer.
Participants will receive a linear anastomat or tubular anastomat for digestive tract reconstruction during distal gastrectomy gastroenterostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linear Anastomat Group (L Group) | Experimental | Device: Linear AnastomatThe duodenum and distal stomach were separated by linear anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the linear anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the linear anastomat. |
| Tubular Anastomat Group (C Group) | Active comparator | Device: Tubular AnastomatThe duodenum and distal stomach were separated by tubular anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the tubular anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the tubular anastomat. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≤ 18 years old ≤75 years old;
- The primary gastric lesions were diagnosed as gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma, and poorly differentiated adenocarcinoma por) by gastroscopic biopsy.
- The patient was clinically diagnosed with gastric cancer (in line with clinical signs of gastrointestinal reconstruction after distal subtotal gastrectomy for gastric cancer);
- Implantation metastasis without peritoneum (confirmed by laparoscopic exploratory surgery);
- It is estimated that R0 results can be obtained after D2 radical resection of distal gastric cancer (also applicable for multiple primary lower cancers);
Key exclusion criteria (18 listed)
- Previous history of upper abdominal surgery (including gastric ESD/EMR, except laparoscopic cholecystectomy);
- History of acute pancreatitis;
- Preoperative imaging examination indicated fusion of enlarged lymph nodes (maximum diameter >3cm);
- Gastric cancer patients who have received neoadjuvant therapy;
- History of other malignant diseases within the past 5 years;
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 |
|---|---|---|
| Linear AnastomatThe product registration certificate numbers of linear anastomat is Su Wei registered 20202021581. | Device | Linear Anastomat Group (L Group) |
| Tubular AnastomatThe product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305. | Device | Tubular Anastomat Group (C Group) |
Primary outcome
Incidence of Intraoperative Splenic Laceration
Time frame: Perioperative period
The number and percentage of participants experiencing splenic laceration during surgery.
Incidence of Positive Incisal Margin
Time frame: Perioperative period
The number and percentage of participants with a positive incisal margin after tumor resection.
Incidence of Anastomosis Failure
Time frame: Perioperative period
The number and percentage of participants experiencing anastomosis failure during surgery.
6 secondary outcomes
Change in Procalcitonin Levels
Time frame: Perioperative period
Change in C-Reactive Protein Levels
Time frame: Perioperative period
Change in TNF-α Levels
Time frame: Perioperative period
Change in Interleukin-6 Levels
Time frame: Perioperative period
Health-Related Quality of Life assessed by EORTC QLQ-C30 Overall Score
Time frame: 3 years
Disease-Specific Quality of Life assessed by EORTC QLQ-STO22 Score
Time frame: 3 years
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 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Anastomat and Tubular Anastomat in people with Gastric Cancer, run by Xiangya Hospital of Central South University 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 18 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Splenic Laceration (time frame: Perioperative period). The study lists 3 primary outcomes in all. 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 23 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.