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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

xiaohua Li, MD,PH.D contact

+8613474299901

xjyylixiaohua@163.com

China1 site, 1 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

    Recruiting

Other trials in China

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.

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 groups in NCT05404256
Study groupRoleWhat they receive
The experimental groupExperimentalRadical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface
Receives: Other: Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
The control groupOtherRadical 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.

  1. 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)
  1. the postoperative mortality

    Postoperative mortality refers to the probability of death within 30 days after radical surgery for gastric cancer

    Measured: 30 days

  2. 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

  3. 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

  4. 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

  5. incidence of postoperative complications

    incidence of postoperative complications

    Measured: 30 days

  6. 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.

  1. First posted3 Jun 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

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)
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

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.

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