Pancreatic NeoplasmsNCT02790333
Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula
A study testing traditional reloads and Tri-Staple reloads in people with Pancreatic Neoplasms and Pancreatic Fistula, run by Yi-Ping Mou at 1 site in China.
Trial summary
The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatic Fistula
- What is being tested?
- traditional reloads and Tri-Staple reloads
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- May 2016to 1 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- disease of pancreatic body and tail
- Age: 18 years or older
- distant metastases are not diagnosed preoperatively.
- Patients who can provide written informed consent
Who cannot join
- Patients with severe organ disease such as cardiac disease,respiratory illness
- Patients with pancreaticojejunostomy,pancreatogastrostomy
- Patients with conversion to laparotomy
- Patients with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy
The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.
Read the detailed description
Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.
- Conditions
- Pancreatic Neoplasms, Pancreatic Fistula
- Being tested
- traditional reloads, Tri-Staple reloads
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional reloadsProcedure or surgery
Blue cartridge with3.0mm height staple was used for pancreatic stump
Tri-Staple reloadsProcedure or surgery
Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump
| Study group | Role | What they receive |
|---|---|---|
| Tri-Staple reloads | Experimental | Tri-Staple reloads were used for pancreatic stump texture Receives: Procedure: Tri-Staple reloads |
| traditional reloads | Active comparator | the traditional reloads were used for pancreatic stump texture Receives: Procedure: traditional reloads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification
Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase > 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later
Measured: Thirty days after operation
Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell
Measured: intraoperative
Secondary outcomes (5)
Morbidity
Measured: Thirty days after operation
Mortality
Measured: Thirty days after operation
Time to oral intake
Measured: Duration of hospital stay
Postoperative hospital stay
Measured: Duration of hospital stay
Readmission rate
Measured: Thirty days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi-Ping Mou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi-Ping Mou, Zhejiang Provincial People's Hospital
- Investigators
- YiPing Mou, MD, Study director, Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790333
- Sponsor's protocol ID
- ZJPPH-04
- Status last verified
- Jan 2021
- First submitted
- 31 May 2016
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT02790333
- Acronym / sponsor ID
- ZJPPH-04
- Conditions
- Pancreatic Neoplasms, Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Yi-Ping MouUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Jun 2016 (estimated)
- 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 purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.
Detailed description
Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tri-Staple reloads | Experimental | Procedure: Tri-Staple reloadsTri-Staple reloads were used for pancreatic stump texture |
| traditional reloads | Active comparator | Procedure: traditional reloadsthe traditional reloads were used for pancreatic stump texture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- disease of pancreatic body and tail
- Age: 18 years or older
- distant metastases are not diagnosed preoperatively.
- Patients who can provide written informed consent
Key exclusion criteria (4 listed)
- Patients with severe organ disease such as cardiac disease,respiratory illness
- Patients with pancreaticojejunostomy,pancreatogastrostomy
- Patients with conversion to laparotomy
- Patients with pregnancy
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 |
|---|---|---|
| traditional reloadsBlue cartridge with3.0mm height staple was used for pancreatic stump | Procedure or surgery | traditional reloads |
| Tri-Staple reloadsPurple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump | Procedure or surgery | Tri-Staple reloads |
Primary outcome
Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification
Time frame: Thirty days after operation
Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase > 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later
Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell
Time frame: intraoperative
5 secondary outcomes
Morbidity
Time frame: Thirty days after operation
Mortality
Time frame: Thirty days after operation
Time to oral intake
Time frame: Duration of hospital stay
Postoperative hospital stay
Time frame: Duration of hospital stay
Readmission rate
Time frame: Thirty days after operation
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 8 Jan 2021.
- 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.
YiPing Mou, MD study director
Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' 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 traditional reloads and Tri-Staple reloads in people with Pancreatic Neoplasms and Pancreatic Fistula, run by Yi-Ping Mou 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 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 8 Jan 2021. 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?
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?
Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification (time frame: Thirty days after operation). The study lists 2 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 8 Jan 2021.