Gastric CancerNCT06464978
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
A study testing Stapler Reinforcement Patch and Standard Stapler in people with Gastric Cancer and Gastrostomy, run by Nanchong Central Hospital at 1 site in China.
Trial summary
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer, Gastrostomy, Anastomotic Leakage
- What is being tested?
- Stapler Reinforcement Patch and Standard Stapler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 31 Dec 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years.
- Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
- ECOG performance status of 0 or 1.
- ASA (American Society of Anesthesiologists) classification of I-III.
- Voluntary signed informed consent from the participant or their legal representative.
Who cannot join
- Evidence of potential distant metastasis found preoperatively.
- History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
- Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
- Participation in any other clinical trial within the last 6 months.
- Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunhong Tian
Nanchong, Sichuan, 637000
Yunhong Tian, PHD, 13508087719, drtianyunhong@126.com
About this study
Official title: The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
Read the detailed description
This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.
- Being tested
- Stapler Reinforcement Patch, Standard Stapler
- Keywords
- Stapler Reinforcement Patch, Gastrojejunostomy, Randomized Controlled Trial, Surgical Outcomes, Complication Prevention
- Medical subject headings
- Stomach Neoplasms, Anastomotic Leak, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapler Reinforcement PatchDevice
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Standard StaplerDevice
Participants in this group will receive gastrojejunostomy with the use of Standard Stapler
| Study group | Role | What they receive |
|---|---|---|
| Stapler Reinforcement Patch Group | Experimental | Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches. Receives: Device: Stapler Reinforcement Patch |
| Standard Stapler Group | Active comparator | Participants in this group will receive gastrojejunostomy with the use of standard staplers. Receives: Device: Standard Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anastomotic Leakage
The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy.
Measured: 30 days post-surgery
Secondary outcomes (4)
Rate of Anastomotic Stricture
The incidence of anastomotic stricture within 3 months post-surgery. Anastomotic stricture is defined as difficulty in food passage or narrowing confirmed by imaging or endoscopy.
Measured: 3 months post-surgery
Postoperative Bleeding Rate
The incidence of postoperative bleeding within 30 days post-surgery. Postoperative bleeding is defined as the occurrence of bleeding requiring intervention or causing significant hemoglobin drop.
Measured: 30 days post-surgery
Mortality Rate
The rate of mortality within 30 days post-surgery.
Measured: 30 days post-surgery
Readmission Rate
Readmission Rate
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start30 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- Model description
- Participants will be randomly assigned to either the experimental group receiving the stapler reinforcement patches or the control group undergoing standard procedures without reinforcement patches.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Collaborators
- Guang'an Central Hospital, Pengan County People's Hospital, Yilong County people's Hospital, Nanbu Hospital of County Chinese Medicine, Langzhong People's Hospital
- Responsible party
- Principal investigator, Yunhong Tian, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464978
- Sponsor's protocol ID
- 20240530
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06464978
- Acronym / sponsor ID
- 20240530
- Keywords
- Stapler Reinforcement Patch, Gastrojejunostomy, Randomized Controlled Trial, Surgical Outcomes, Complication Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Collaborators
- Guang'an Central Hospital, Pengan County People's Hospital, Yilong County people's Hospital, Nanbu Hospital of County Chinese Medicine, Langzhong People's Hospital
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Jun 2024 (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.
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
Detailed description
This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the experimental group receiving the stapler reinforcement patches or the control group undergoing standard procedures without reinforcement patches.
| Arm | Type | Receives |
|---|---|---|
| Stapler Reinforcement Patch Group | Experimental | Device: Stapler Reinforcement PatchParticipants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches. |
| Standard Stapler Group | Active comparator | Device: Standard StaplerParticipants in this group will receive gastrojejunostomy with the use of standard staplers. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 85 years.
- Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
- ECOG performance status of 0 or 1.
- ASA (American Society of Anesthesiologists) classification of I-III.
- Voluntary signed informed consent from the participant or their legal representative.
Key exclusion criteria (5 listed)
- Evidence of potential distant metastasis found preoperatively.
- History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
- Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
- Participation in any other clinical trial within the last 6 months.
- Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
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 |
|---|---|---|
| Stapler Reinforcement PatchParticipants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches. | Device | Stapler Reinforcement Patch Group |
| Standard StaplerParticipants in this group will receive gastrojejunostomy with the use of Standard Stapler | Device | Standard Stapler Group |
Primary outcome
Rate of Anastomotic Leakage
Time frame: 30 days post-surgery
The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy.
4 secondary outcomes
Rate of Anastomotic Stricture
Time frame: 3 months post-surgery
Postoperative Bleeding Rate
Time frame: 30 days post-surgery
Mortality Rate
Time frame: 30 days post-surgery
Readmission Rate
Time frame: 3 months post-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 31 Mar 2026.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapler Reinforcement Patch and Standard Stapler in people with Gastric Cancer and Gastrostomy, run by Nanchong Central 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anastomotic Leakage (time frame: 30 days post-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 31 Mar 2026.