Pancreatic FistulaNCT05404256
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
A study testing Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface and Radical gastrectomy +D2 lymphadenectomy in people with Pancreatic Fistula, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface and Radical gastrectomy +D2 lymphadenectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histological confirmation of gastric adenocarcinoma
- Stage cT1-4a, N0-3, M0 (according to the 8th AJCC TNM staging system)
- For locally advanced tumors (cT3-4aN+M0), preoperative completion of all three cycles of chemotherapy (SOX)
- 18-75 years old
- No incurable factors such as cancer cell metastasis in other organs
- Written informed consent signed voluntarily
Who cannot join
- Assessment of preoperative or intraoperative requiring pancreatic resection
- Gastric cancer-related emergency surgery
- Gastric stump carcinoma
- In cases of distant metastasis discovered during operation, only abdominal exploration or palliative surgery were adopt.
- Uncontrolled seizures, central nervous system diseases or mental disorders
- Uncorrectable coagulation dysfunction
Show all 9Show fewer
- Severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases
- Diseases requiring immunosuppressive treatment, such as organ transplantation, SLE, etc
- Other diseases requiring simultaneous surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, 710032
xiaohua li, MD, PH.D, 13474299901, lixiaohua1982@fmmu.edu.cn
zhenchang mo, 18229712293, mzc131208@126.com
About this study
Official title: Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissuePatchTM Cover the Wound Surface of Pancreatic Capsule
Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.
Read the detailed description
Gastric cancer is the fifth most common tumor and the fourth most deadly cancer disease in the world. Surgical resection is the recommended method to cure gastric cancer. In recent years, with the continuous promotion of D2 radical gastrectomy and the rapid development of new technologies such as laparoscopic and robotic surgical systems, although the incidence of complications such as abdominal bleeding, anastomotic leakage and abdominal infection has decreased, but the incidence of Postoperative pancreatic fistula is increasing. Postoperative pancreatic fistula involves the delivery of any measurable volume of fluid through surgically placed drainage tubes, and amylase activity is 3 times higher than the upper limit of normal plasma value. According to the severity of postoperative pancreatic fistula, there are three grades: A, B and C. Grade A pancreatic fistula is mainly biochemical leak (BL), not pancreatic fistula in the real sense. Grade B pancreatic fistula requires a definite change in postoperative treatment strategy, which affects the postoperative process. Continuous drainage of drainage tube in situ for > 3 weeks, or percutaneous or subultrasonic drainage is required; Grade C pancreatic fistula refers to the situation of secondary surgery, single or multiple organ failure (especially respiratory, cardiac and renal insufficiency) and even death caused by postoperative pancreatic fistula. The risk factors of pancreatic fistula after radical gastrectomy for gastric cancer mainly include: 1. Surgical methods and instrument-related factors, such as the scope of surgical resection and lymph node dissection; 2. Pancreatic factors, soft pancreas showed less fibrous tissue, inflammatory cells infiltrating pancreatic tissue and pancreatic edema, and pancreatic fistula was more likely to occur during surgery; 3. Basic information of the patient: obesity is an important risk factor for pancreatic fistula. Currently, laparoscopic surgery has been widely carried out in gastric cancer, but due to the characteristics of laparoscopic surgery and the difference in operator experience, the incidence of postoperative pancreatic fistula is higher than that of open surgery. Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. Due to the digestion of pancreatic fluid, severe pancreatic fistula is often followed by abdominal infection, postoperative bleeding, anastomotic fistula and other serious complications, even life-threatening. Therefore, the prevention and early detection of pancreatic fistula after radical gastrectomy of gastric cancer is very important. At present, there are few studies on the prevention of pancreatic fistula after gastric cancer surgery at home and abroad. The main preventive surgeries require surgeons to perform fine operations and also require individual drainage methods. These methods can reduce the occurrence of pancreatic fistula after gastric cancer surgery to a certain extent, but have weak preventive effect on the large scope of lymph node dissection. TissuePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent air, blood, and fluid leakage during neurosurgery, spine, chest, and soft tissue surgery. It is a pre-formed patch with built-in adhesive strength. It also incorporates TissuebondTM, a bio-bonding polymer that forms strong covalent bonds to protein-rich tissue surfaces. Adhesion is achieved when the prefabricated membrane is applied to the tissue bed with moderate pressure of 60 seconds, which allows contact adhesion and eliminates potential tissue space. Studies have shown that the use of TissuePatchTM in major neck surgery can effectively prevent the occurrence of chylous leakage and promote the recovery of patients. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients. Therefore, based on our experience and foundation in the treatment of gastric cancer in gastrointestinal surgery, the real world observation and research on the experimental treatment plan for the prevention of pancreatic fistula in gastric cancer patients after surgery will be carried out, and the integration of domestic superior resources will surely further promote the development of the prevention of pancreatic fistula after radical gastrectomy for gastric cancer.
- Conditions
- Pancreatic Fistula
- Being tested
- Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface, Radical gastrectomy +D2 lymphadenectomy
- Keywords
- TissuePatchTM, radical gastrectomy, postoperative pancreatic fistula
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surfaceOther
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Radical gastrectomy +D2 lymphadenectomyOther
Radical gastrectomy +D2 lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Radical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface Receives: Other: Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface |
| The control group | Other | Radical gastrectomy +D2 lymphadenectomy Receives: Other: Radical gastrectomy +D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula after radical gastrectomy
Postoperative pancreatic fistula, in which any measurable volume of fluid is delivered through a surgically placed drainage tube, has amylase activity greater than 3 times the upper limit of normal plasma value
Measured: 3 days
Secondary outcomes (6)
the postoperative mortality
Postoperative mortality refers to the probability of death within 30 days after radical surgery for gastric cancer
Measured: 30 days
length of postoperative hospital stay
Postoperative hospital stay refers to the time between the date of operation and the date of discharge
Measured: Up to 30 days
Classification of pancreatic fistula
The classification of pancreatic fistula included the incidence of biochemical fistula, grade B pancreatic fistula and grade C pancreatic fistula.
Measured: 3 days
number of lymph nodes dissection
The number of lymph nodes dissected refers to the total number of lymph nodes dissected during the operation
Measured: 1 days
incidence of postoperative complications
incidence of postoperative complications
Measured: 30 days
incidence of TissuePatchTM related complications
intestinal adhesion, intestinal obstruction, parenchymal atrophy of the pancreas, chronic pancreatitis, and allergic reactions and so on.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaohua li, Xijing Hospital of Digestive Diseases
- Investigators
- xiaohua li, MD,PH.D, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404256
- Sponsor's protocol ID
- XJ013
- Status last verified
- May 2024
- First submitted
- 30 May 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yue C, Mo Z, Yang Q, Yu P, Zhou H, Gao R, Wang W, Guo Z, Zhang C, Wang Y, Ji P, Wu X, Zhang Y, Ji G, Li X. Comparison of the efficacy of TissuePatch versus no TissuePatch to seal pancreatic tissue surface for the prevention of pancreatic fistula after radical gastrectomy: study protocol for a prospective, single-center, randomized controlled trial. Trials. 2025 Dec 28;27(1):92. doi: 10.1186/s13063-025-09144-7.
PubMed 41456003
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissuePatchTM Cover the Wound Surface of Pancreatic Capsule
- ClinicalTrials.gov ID
- NCT05404256
- Acronym / sponsor ID
- XJ013
- Conditions
- Pancreatic Fistula
- Keywords
- TissuePatchTM, radical gastrectomy, postoperative pancreatic fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Jun 2022 (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.
Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.
Detailed description
Gastric cancer is the fifth most common tumor and the fourth most deadly cancer disease in the world. Surgical resection is the recommended method to cure gastric cancer. In recent years, with the continuous promotion of D2 radical gastrectomy and the rapid development of new technologies such as laparoscopic and robotic surgical systems, although the incidence of complications such as abdominal bleeding, anastomotic leakage and abdominal infection has decreased, but the incidence of Postoperative pancreatic fistula is increasing. Postoperative pancreatic fistula involves the delivery of any measurable volume of fluid through surgically placed drainage tubes, and amylase activity is 3 times higher than the upper limit of normal plasma value. According to the severity of postoperative pancreatic fistula, there are three grades: A, B and C. Grade A pancreatic fistula is mainly biochemical leak (BL), not pancreatic fistula in the real sense. Grade B pancreatic fistula requires a definite change in postoperative treatment strategy, which affects the postoperative process. Continuous drainage of drainage tube in situ for > 3 weeks, or percutaneous or subultrasonic drainage is required; Grade C pancreatic fistula refers to the situation of secondary surgery, single or multiple organ failure (especially respiratory, cardiac and renal insufficiency) and even death caused by postoperative pancreatic fistula. The risk factors of pancreatic fistula after radical gastrectomy for gastric cancer mainly include: 1. Surgical methods and instrument-related factors, such as the scope of surgical resection and lymph node dissection; 2. Pancreatic factors, soft pancreas showed less fibrous tissue, inflammatory cells infiltrating pancreatic tissue and pancreatic edema, and pancreatic fistula was more likely to occur during surgery; 3. Basic information of the patient: obesity is an important risk factor for pancreatic fistula. Currently, laparoscopic surgery has been widely carried out in gastric cancer, but due to the characteristics of laparoscopic surgery and the difference in operator experience, the incidence of postoperative pancreatic fistula is higher than that of open surgery. Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. Due to the digestion of pancreatic fluid, severe pancreatic fistula is often followed by abdominal infection, postoperative bleeding, anastomotic fistula and other serious complications, even life-threatening. Therefore, the prevention and early detection of pancreatic fistula after radical gastrectomy of gastric cancer is very important. At present, there are few studies on the prevention of pancreatic fistula after gastric cancer surgery at home and abroad. The main preventive surgeries require surgeons to perform fine operations and also require individual drainage methods. These methods can reduce the occurrence of pancreatic fistula after gastric cancer surgery to a certain extent, but have weak preventive effect on the large scope of lymph node dissection. TissuePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent air, blood, and fluid leakage during neurosurgery, spine, chest, and soft tissue surgery. It is a pre-formed patch with built-in adhesive strength. It also incorporates TissuebondTM, a bio-bonding polymer that forms strong covalent bonds to protein-rich tissue surfaces. Adhesion is achieved when the prefabricated membrane is applied to the tissue bed with moderate pressure of 60 seconds, which allows contact adhesion and eliminates potential tissue space. Studies have shown that the use of TissuePatchTM in major neck surgery can effectively prevent the occurrence of chylous leakage and promote the recovery of patients. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients. Therefore, based on our experience and foundation in the treatment of gastric cancer in gastrointestinal surgery, the real world observation and research on the experimental treatment plan for the prevention of pancreatic fistula in gastric cancer patients after surgery will be carried out, and the integration of domestic superior resources will surely further promote the development of the prevention of pancreatic fistula after radical gastrectomy for gastric cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Other: Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surfaceRadical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface |
| The control group | Other | Other: Radical gastrectomy +D2 lymphadenectomyRadical gastrectomy +D2 lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological confirmation of gastric adenocarcinoma
- Stage cT1-4a, N0-3, M0 (according to the 8th AJCC TNM staging system)
- For locally advanced tumors (cT3-4aN+M0), preoperative completion of all three cycles of chemotherapy (SOX)
- 18-75 years old
- No incurable factors such as cancer cell metastasis in other organs
Key exclusion criteria (9 listed)
- Assessment of preoperative or intraoperative requiring pancreatic resection
- Gastric cancer-related emergency surgery
- Gastric stump carcinoma
- In cases of distant metastasis discovered during operation, only abdominal exploration or palliative surgery were adopt.
- Uncontrolled seizures, central nervous system diseases or mental disorders
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 |
|---|---|---|
| Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surfaceRadical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface | Other | The experimental group |
| Radical gastrectomy +D2 lymphadenectomyRadical gastrectomy +D2 lymphadenectomy | Other | The control group |
Primary outcome
Incidence of pancreatic fistula after radical gastrectomy
Time frame: 3 days
Postoperative pancreatic fistula, in which any measurable volume of fluid is delivered through a surgically placed drainage tube, has amylase activity greater than 3 times the upper limit of normal plasma value
6 secondary outcomes
the postoperative mortality
Time frame: 30 days
length of postoperative hospital stay
Time frame: Up to 30 days
Classification of pancreatic fistula
Time frame: 3 days
number of lymph nodes dissection
Time frame: 1 days
incidence of postoperative complications
Time frame: 30 days
incidence of TissuePatchTM related complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41456003Yue C, Mo Z, Yang Q, Yu P, Zhou H, Gao R, Wang W, Guo Z, Zhang C, Wang Y, Ji P, Wu X, Zhang Y, Ji G, Li X. Comparison of the efficacy of TissuePatch versus no TissuePatch to seal pancreatic tissue surface for the prevention of pancreatic fistula after radical gastrectomy: study protocol for a prospective, single-center, randomized controlled trial. Trials. 2025 Dec 28;27(1):92. doi: 10.1186/s13063-025-09144-7.
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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.
xiaohua li, MD,PH.D study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface and Radical gastrectomy +D2 lymphadenectomy in people with Pancreatic Fistula, run by Xijing Hospital of Digestive Diseases 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 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaohua Li, MD,PH.D (+8613474299901, xjyylixiaohua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pancreatic fistula after radical gastrectomy (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404256, which also lists 1 linked publication.
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 8 May 2024.