Omental PatchNCT04704882
A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd
A study testing omental patchwork in people with Omental Patch and Laparoscopic Pancreaticoduodenectomy, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Omental Patch, Laparoscopic Pancreaticoduodenectomy, Pancreatic Fistula
- What is being tested?
- omental patchwork
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 May 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Disease of periampullary or pancreatic head tumor
- . 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 extended LPD or vessels reconstruction
- Patients with conversion to laparotomy
- . Patients with pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, 314000
tao xia, doctor, +8618653268206, xiatao13@163.com
About this study
Official title: A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Further, some trials showed LPD got less morbidity and shorter length of stay. Pancreatic fistula is the major complication for pancreaticodupdenectomy and associated with numerous serious complications, suffering reoperation or sometimes death. The reported rate was 10% to 55%. A lot of modified procedure have been proposed to reduce pancreatic fistula. Omental flaps around anastomosis have been used to prevent post pancreaticoduodenectomy fistula or hemorrhage. However, the outcomes are controversy. A modified omental patch work has been used during LPD and the initial outcomes are good. This is a pilot study to evaluate the function of the modified omental patch work on decreasing the pancreatic fistula.
- Being tested
- omental patchwork
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omental patchworkOther
the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels
| Study group | Role | What they receive |
|---|---|---|
| omental patchwork group | Experimental | Not described Receives: Other: omental patchwork |
| non-omental patchwork group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic fistula
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
Measured: 90 days
Secondary outcomes (3)
morbidity
Measured: 90 days
Mortality
Measured: 90 days
Postoperative hospital stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Jan 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omental PatchStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ping Mou, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704882
- Sponsor's protocol ID
- ZJPPHGIP-RCT2019001
- Status last verified
- Dec 2021
- First submitted
- 4 Jan 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT04704882
- Acronym / sponsor ID
- ZJPPHGIP-RCT2019001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 12 Jan 2021 (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.
Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Further, some trials showed LPD got less morbidity and shorter length of stay. Pancreatic fistula is the major complication for pancreaticodupdenectomy and associated with numerous serious complications, suffering reoperation or sometimes death. The reported rate was 10% to 55%. A lot of modified procedure have been proposed to reduce pancreatic fistula. Omental flaps around anastomosis have been used to prevent post pancreaticoduodenectomy fistula or hemorrhage. However, the outcomes are controversy. A modified omental patch work has been used during LPD and the initial outcomes are good. This is a pilot study to evaluate the function of the modified omental patch work on decreasing the pancreatic fistula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omental patchwork group | Experimental | Other: omental patchwork |
| non-omental patchwork group | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . Disease of periampullary or pancreatic head tumor
- . 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 extended LPD or vessels reconstruction
- 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 |
|---|---|---|
| omental patchworkthe omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels | Other | omental patchwork group |
Primary outcome
pancreatic fistula
Time frame: 90 days
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
3 secondary outcomes
morbidity
Time frame: 90 days
Mortality
Time frame: 90 days
Postoperative hospital stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Perforated Peptic Ulcer, Peptic Ulcer Perforation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omental patchwork in people with Omental Patch and Laparoscopic Pancreaticoduodenectomy, run by Zhejiang Provincial People's 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 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: status not confirmed, as of the sponsor's last update on 8 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ping yi mou, doctor (+8613605818289, yipingmou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic fistula (time frame: 90 days). 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 Dec 2021.