Pancreatic FistulaPhase 3NCT03419676
Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy
A Phase 3 study testing Hemopatch in people with Pancreatic Fistula, run by Hospital Miguel Servet at 1 site in Spain.
Trial summary
The objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Hemopatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 10 Feb 2022
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score < 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
Who cannot join
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score < 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula
The objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process.
Read the detailed description
Pancreaticoduodenectomy (PD) is the most common surgical procedure to treat pancreatic tumors in the head of the pancreas and periampullary region, as well as benign processes such as chronic pancreatitis. Recent advances in surgical techniques and perioperative treatments have reduced perioperative mortality below 10% in high volume centers. However, PD is associated with considerable morbidity (40-58.5%) like postoperative pancreatic fistula, delayed gastric emptying, biliary fistula, postoperative hemorrhage, and pulmonary complications.
Several surgical techniques and perioperative care have been described to prevent or reduce the incidence of pancreatic fistula after PD, including reconstruction of the digestive tract with pancreaticogastrostomy, duc-to-mucosa reconstruction or pancreaticojejunostomy by intussusception, use of somatostatin and prophylactic analogues, the use of stents in the main pancreatic duct, and use of different sealants.
Although perioperative morbidity and mortality associated with PD have improved significantly over the years, even in high-volume centers, the incidence of postoperative fistula remains at 9.9-28.5%. Therefore, the ideal pancreatic reconstruction technique that prevents fistula is not yet available.
The use of sealants has been one of the approaches taken to try to reduce the rate of fistulas. Some uncontrolled or non-randomized studies have shown that the use of fibrin glue-based adhesives in combinations with felting patches can lead to a B / C grade fistula rate of 0-10%. Only 2 randomized clinical trials have been performed with fibrin glue, with opposite results in terms of significant reduction of pancreatic fistula.
Hemopatch is a patch consisting of a soft, thin and flexible pad of collagen derived from the bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). It is intended to be a surgical sealant for procedures in which control of leakage by conventional surgical techniques is ineffective or impractical, making it a plausible option to use during PD in order to decrease postoperative pancreatic fistula.
- Conditions
- Pancreatic Fistula
- Being tested
- Hemopatch
- Keywords
- Pancreatoduodenectomy, Postoperative pancreatic fistula, Sealant, Hemopatch
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchDevice
Collagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No reinforcement. |
| Hemopatch | Experimental | Reinforcement with Hemopatch. Receives: Device: Hemopatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative type B and C pancreatic fistula
Postoperative type B and C pancreatic fistula rate defined according to the International Study Group of Pancreatic Fistula criteria, measured by amylases and/or lipases levels in the perianastomotic drainage
Measured: Up to 3 months
Secondary outcomes (10)
Hospital stay
Days of duration
Measured: Up to 3 months
Stay in intensive care unit
Days of duration
Measured: Up to 3 months
Total postoperative fistula (including type A, B, and C)
Percentage of patients
Measured: Up to 3 months
Reoperations including interventional radiology
Percentage of patients
Measured: Up to 3 months
Delayed gastric emptying
Percentage of patients
Measured: Up to 3 months
Biliary fistula
Percentage of patients
Measured: Up to 3 months
Hemorrhage
Percentage of patients
Measured: Up to 3 months
Deep organ space complications
Deep organ space complications
Measured: Up to 3 months
Death, irrespective of cause
Death
Measured: Up to 3 months
Overall complications (according to Clavien-Dindo classification)
Percentage of patients
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 May 2018
- Primary completion30 Jun 2020
- Study completion10 Feb 2022
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patient data are anonymous. Each patient who meets the selection criteria and has signed the informed consent will be entered into a database and identified by a number (from 1 to 64). The list of patient identification numbers will be in the hands of the principal investigator. After carrying out the surgery, the patient number is entered into an online computerized randomization tool ("Randomizer for clinical trials"), https://www.meduniwien.ac.at/randomizer. It is a tool of the University of Vienna in Austria, where it is registered in a study, which allows, once the patient number is entered, the randomization of the same, obtaining one of the two methods to compare (32 patients in each study group): 1. Basic treatment: duct-to-mucosa pancreaticojejunostomy WITHOUT Hemopatch reinforcement. 2. The same, but reinforced WITH Hemopatch. Once the treatment to be performed is obtained, surgery will be carried out according to the treatment obtained in the randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Aragon Health Science Institute
- Responsible party
- Principal investigator, Mario Serradilla, MD, FACS, Hospital Miguel Servet
- Investigators
- Mario Serradilla, Principal investigator, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419676
- Sponsor's protocol ID
- C1834-MADIT
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2017
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Serradilla-Martin M, Paterna-Lopez S, Palomares-Cano A, Cantalejo-Diaz M, Abadia-Forcen T, Gutierrez-Diez ML, Artigas-Marco C, Serrablo-Requejo A. Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial. BJS Open. 2023 Mar 7;7(2):zrad028. doi: 10.1093/bjsopen/zrad028.
PubMed 37021546
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula
- ClinicalTrials.gov ID
- NCT03419676
- Acronym / sponsor ID
- C1834-MADIT
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreatoduodenectomy, Postoperative pancreatic fistula, Sealant, Hemopatch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Aragon Health Science Institute
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 5 Feb 2018 (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 objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process.
Detailed description
Pancreaticoduodenectomy (PD) is the most common surgical procedure to treat pancreatic tumors in the head of the pancreas and periampullary region, as well as benign processes such as chronic pancreatitis. Recent advances in surgical techniques and perioperative treatments have reduced perioperative mortality below 10% in high volume centers. However, PD is associated with considerable morbidity (40-58.5%) like postoperative pancreatic fistula, delayed gastric emptying, biliary fistula, postoperative hemorrhage, and pulmonary complications.
Several surgical techniques and perioperative care have been described to prevent or reduce the incidence of pancreatic fistula after PD, including reconstruction of the digestive tract with pancreaticogastrostomy, duc-to-mucosa reconstruction or pancreaticojejunostomy by intussusception, use of somatostatin and prophylactic analogues, the use of stents in the main pancreatic duct, and use of different sealants.
Although perioperative morbidity and mortality associated with PD have improved significantly over the years, even in high-volume centers, the incidence of postoperative fistula remains at 9.9-28.5%. Therefore, the ideal pancreatic reconstruction technique that prevents fistula is not yet available.
The use of sealants has been one of the approaches taken to try to reduce the rate of fistulas. Some uncontrolled or non-randomized studies have shown that the use of fibrin glue-based adhesives in combinations with felting patches can lead to a B / C grade fistula rate of 0-10%. Only 2 randomized clinical trials have been performed with fibrin glue, with opposite results in terms of significant reduction of pancreatic fistula.
Hemopatch is a patch consisting of a soft, thin and flexible pad of collagen derived from the bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). It is intended to be a surgical sealant for procedures in which control of leakage by conventional surgical techniques is ineffective or impractical, making it a plausible option to use during PD in order to decrease postoperative pancreatic fistula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All patient data are anonymous. Each patient who meets the selection criteria and has signed the informed consent will be entered into a database and identified by a number (from 1 to 64). The list of patient identification numbers will be in the hands of the principal investigator. After carrying out the surgery, the patient number is entered into an online computerized randomization tool ("Randomizer for clinical trials"), https://www.meduniwien.ac.at/randomizer. It is a tool of the University of Vienna in Austria, where it is registered in a study, which allows, once the patient number is entered, the randomization of the same, obtaining one of the two methods to compare (32 patients in each study group): 1. Basic treatment: duct-to-mucosa pancreaticojejunostomy WITHOUT Hemopatch reinforcement. 2. The same, but reinforced WITH Hemopatch. Once the treatment to be performed is obtained, surgery will be carried out according to the treatment obtained in the randomization.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No reinforcement. |
| Hemopatch | Experimental | Device: HemopatchReinforcement with Hemopatch. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score < 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
Key exclusion criteria (4 listed)
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score < 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
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 |
|---|---|---|
| HemopatchCollagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed. | Device | Hemopatch |
Primary outcome
Postoperative type B and C pancreatic fistula
Time frame: Up to 3 months
Postoperative type B and C pancreatic fistula rate defined according to the International Study Group of Pancreatic Fistula criteria, measured by amylases and/or lipases levels in the perianastomotic drainage
10 secondary outcomes
Hospital stay
Time frame: Up to 3 months
Stay in intensive care unit
Time frame: Up to 3 months
Total postoperative fistula (including type A, B, and C)
Time frame: Up to 3 months
Reoperations including interventional radiology
Time frame: Up to 3 months
Delayed gastric emptying
Time frame: Up to 3 months
Biliary fistula
Time frame: Up to 3 months
Hemorrhage
Time frame: Up to 3 months
Deep organ space complications
Time frame: Up to 3 months
Death, irrespective of cause
Time frame: Up to 3 months
Overall complications (according to Clavien-Dindo classification)
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 37021546Serradilla-Martin M, Paterna-Lopez S, Palomares-Cano A, Cantalejo-Diaz M, Abadia-Forcen T, Gutierrez-Diez ML, Artigas-Marco C, Serrablo-Requejo A. Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial. BJS Open. 2023 Mar 7;7(2):zrad028. doi: 10.1093/bjsopen/zrad028.
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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.
Mario Serradilla principal investigator
Hospital Miguel Servet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hemopatch in people with Pancreatic Fistula, run by Hospital Miguel Servet at 1 site in Spain.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Feb 2022. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative type B and C pancreatic fistula (time frame: Up to 3 months). 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 NCT03419676, 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 11 Feb 2022.