Pancreatic FistulaNCT05657366
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
A study testing Peritoneal lavage in people with Pancreatic Fistula and Pancreaticoduodenal; Fistula, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Fistula, Pancreaticoduodenal; Fistula
- What is being tested?
- Peritoneal lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
- Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
- Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.
Who cannot join
- Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
- Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;
- Patients and their families do not understand the treatment implementation plan of this study;
- Failure to complete follow-up;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores
As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.
In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.
- Conditions
- Pancreatic Fistula, Pancreaticoduodenal; Fistula
- Being tested
- Peritoneal lavage
- Medical subject headings
- Pancreatic Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal lavageProcedure or surgery
Continuous abdominal flushing with normal saline
| Study group | Role | What they receive |
|---|---|---|
| low and medium risk（a-FRS）lavage | Experimental | alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), lavage Receives: Procedure: Peritoneal lavage |
| low and medium risk（a-FRS） no lavage | No intervention | alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), no lavage |
| high risk（a-FRS）lavage | Experimental | alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) lavage Receives: Procedure: Peritoneal lavage |
| high risk（a-FRS）no lavage | No intervention | alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) no lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pancreatic Fistula (POPF)
Presence of Amylase > 3 times the upper limit of normal in surgical drains
Measured: 30 days post-operative
Secondary outcomes (11)
Biliary fistula
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Measured: 90 days post-operative
Post-Pancreatectomy Hemorrhage
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Measured: 90 days post-operative
Mortality
Death related to surgical morbidity
Measured: 90 days post-operative
Delayed Gastric Emptying
As defined by ISGPS, grade A, B and C rates
Measured: 90 days post-operative
Abdominal abscess or infection
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Measured: 90 days post-operative
Gastrojejunal/Duodenojejunal fistula
Fistula from gastro/duodenojejunostomy
Measured: 90 days post-operative
Wound infection
Superficial and Deep Surgical Site Incisional Infection
Measured: 90 days post-operative
Length of Hospital Stay
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Measured: 1 year post-operative
Reoperation
Need for new surgery due to severe morbidity
Measured: 90 days post-operative
Readmission
New admission within 30-days of discharge from hospital
Measured: 30 days post-operative
drainage tube duration
Retention time of abdominal drainage tube
Measured: 90 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657366
- Sponsor's protocol ID
- zyeyPDlavage
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores
- ClinicalTrials.gov ID
- NCT05657366
- Acronym / sponsor ID
- zyeyPDlavage
- Conditions
- Pancreatic Fistula, Pancreaticoduodenal; Fistula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Dec 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.
As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.
In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low and medium risk（a-FRS）lavage | Experimental | Procedure: Peritoneal lavagealternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), lavage |
| low and medium risk（a-FRS） no lavage | No intervention | –alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), no lavage |
| high risk（a-FRS）lavage | Experimental | Procedure: Peritoneal lavagealternative pancreatic fistula risk score system，a-FRS high risk group (>20%) lavage |
| high risk（a-FRS）no lavage | No intervention | –alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) no lavage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
- Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
- Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.
Key exclusion criteria (4 listed)
- Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
- Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;
- Patients and their families do not understand the treatment implementation plan of this study;
- Failure to complete follow-up;
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 |
|---|---|---|
| Peritoneal lavageContinuous abdominal flushing with normal saline | Procedure or surgery | high risk（a-FRS）lavage, low and medium risk（a-FRS）lavage |
Primary outcome
Post-operative Pancreatic Fistula (POPF)
Time frame: 30 days post-operative
Presence of Amylase > 3 times the upper limit of normal in surgical drains
11 secondary outcomes
Biliary fistula
Time frame: 90 days post-operative
Post-Pancreatectomy Hemorrhage
Time frame: 90 days post-operative
Mortality
Time frame: 90 days post-operative
Delayed Gastric Emptying
Time frame: 90 days post-operative
Abdominal abscess or infection
Time frame: 90 days post-operative
Gastrojejunal/Duodenojejunal fistula
Time frame: 90 days post-operative
Wound infection
Time frame: 90 days post-operative
Length of Hospital Stay
Time frame: 1 year post-operative
Reoperation
Time frame: 90 days post-operative
Readmission
Time frame: 30 days post-operative
drainage tube duration
Time frame: 90 days post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Yes
Related trials for Pancreatic Fistula
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Not yet recruitingObservational study
Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Pancreaticoduodenectomy
Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingObservational study
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
Pancreatic Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal lavage in people with Pancreatic Fistula and Pancreaticoduodenal; Fistula, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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: opening soon, as of the sponsor's last update on 21 Apr 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanbing Zhu, PhD (15857174159, juvanbn@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pancreatic Fistula (POPF) (time frame: 30 days post-operative). 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 21 Apr 2023.