Pancreatic FistulaNCT03600584
Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
A study testing Modified one-layer duct-to-mucosa Pancreaticojejunostomy and Invagination pancreaticojejunostomy in people with Pancreatic Fistula, run by Nanjing Medical University at 1 site in China.
Trial summary
The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy 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?
- Modified one-layer duct-to-mucosa Pancreaticojejunostomy and Invagination pancreaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Mar 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed consent obtained；
- Both sexes between 18 and 80 years old；
- Patients scheduled to elective open pancreaticoduodenectomy.
Who cannot join
- Patients with ASA score >=4;
- Patients who had a previous pancreatic operation;
- Patients with an immunodeficiency;
- Patients who underwent an emergency operation;
- Pregnant patients；
- Patients who was found that pancreaticoduodenectomy was not suitable。
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029
Yi Miao, PhD, miaoyi@njmu.edu.cn
About this study
Official title: Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy
Read the detailed description
Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ.
This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.
- Conditions
- Pancreatic Fistula
- Being tested
- Modified one-layer duct-to-mucosa Pancreaticojejunostomy, Invagination pancreaticojejunostomy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified one-layer duct-to-mucosa PancreaticojejunostomyProcedure or surgery
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.
Invagination pancreaticojejunostomyProcedure or surgery
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.
| Study group | Role | What they receive |
|---|---|---|
| One-layer duct-to-mucosa Group | Experimental | Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy. Receives: Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy |
| Invagination Group | Active comparator | Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy. Receives: Procedure: Invagination pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically relevant postoperative pancreatic fistula (POPF)
As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
Measured: Up to 60 days after Surgery
Secondary outcomes (9)
Anastomosis time
Time from the beginning to the end of the pancreatic reconstruction
Measured: intraoperatively
Delayed gastric emptying
The International Study Group for Pancreatic Surgery definition and classification of delayed gastric emptying were applied. Briefly, grade A, unable to tolerate solid oral intake by POD 7 and usually no vomiting; grade B, unable to tolerate solid oral intake by POD 14 with/without vomiting: and grade C, unable to tolerate solid oral intake by POD 21 with/without vomiting.
Measured: Up to 60 day after Surgery
post-pancreatectomy hemorrhage (PPH)
The 2017 International Study Group for Pancreatic Surgery definition and classification of PPH were applied.
Measured: Up to 60 days after Surgery
Chyle leak
The 2017 International Study Group for Pancreatic Surgery definition and classification of chyle leak were applied.
Measured: Up to 60 days after Surgery
Overall Morbidity
Any complications that occur postoperatively. The severity of complications was graded according to the Clavien-Dindo classification.
Measured: Up to 60 days after Surgery
Mortality
Patient death that occurs postoperatively
Measured: Up to 90 days after Surgery
Reoperation rate
Patients who needs a surgical re-operation for any reasons during the postoperative hosptial stay. Reasons and times of reoperation are recorded.
Measured: Up to 90 days after Surgery
Readmission rate
Patients that readmitted into hospital for reasons that related to complications of last pancreatic surgery.
Measured: Up to 60 days after Surgery
Duration of postoperative hospital stay
Time from day of operation to day of discharge
Measured: Up to 90 days after Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Miao, Prof., Nanjing Medical University
- Investigators
- Miao, Prof., Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600584
- Sponsor's protocol ID
- JSPH-PC-201801
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei J, Liu X, Wu J, Xu W, Zhou J, Lu Z, Chen J, Guo F, Gao W, Li Q, Jiang K, Dai C, Miao Y. Modified One-layer Duct-to-mucosa Pancreaticojejunostomy Reduces Pancreatic Fistula After Pancreaticoduodenectomy. Int Surg. 2015 Jun 3. doi: 10.9738/INTSURG-D-15-00094.1. Online ahead of print.
PubMed 26037262Hai H, Li Z, Zhang Z, Cheng Y, Liu Z, Gong J, Deng Y. Duct-to-mucosa versus other types of pancreaticojejunostomy for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD013462. doi: 10.1002/14651858.CD013462.pub2.
PubMed 35289922
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03600584
- Acronym / sponsor ID
- JSPH-PC-201801
- Conditions
- Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 26 Jul 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 aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy
Detailed description
Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ.
This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-layer duct-to-mucosa Group | Experimental | Procedure: Modified one-layer duct-to-mucosa PancreaticojejunostomyModified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy. |
| Invagination Group | Active comparator | Procedure: Invagination pancreaticojejunostomyInvagination pancreaticojejunostomy is used after pancreaticoduodenectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written Informed consent obtained；
- Both sexes between 18 and 80 years old；
- Patients scheduled to elective open pancreaticoduodenectomy.
Key exclusion criteria (6 listed)
- Patients with ASA score >=4;
- Patients who had a previous pancreatic operation;
- Patients with an immunodeficiency;
- Patients who underwent an emergency operation;
- Pregnant patients；
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 |
|---|---|---|
| Modified one-layer duct-to-mucosa PancreaticojejunostomyAfter the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed. | Procedure or surgery | One-layer duct-to-mucosa Group |
| Invagination pancreaticojejunostomyAfter the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed. | Procedure or surgery | Invagination Group |
Primary outcome
Rate of clinically relevant postoperative pancreatic fistula (POPF)
Time frame: Up to 60 days after Surgery
As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
9 secondary outcomes
Anastomosis time
Time frame: intraoperatively
Delayed gastric emptying
Time frame: Up to 60 day after Surgery
post-pancreatectomy hemorrhage (PPH)
Time frame: Up to 60 days after Surgery
Chyle leak
Time frame: Up to 60 days after Surgery
Overall Morbidity
Time frame: Up to 60 days after Surgery
Mortality
Time frame: Up to 90 days after Surgery
Reoperation rate
Time frame: Up to 90 days after Surgery
Readmission rate
Time frame: Up to 60 days after Surgery
Duration of postoperative hospital stay
Time frame: Up to 90 days after Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 26037262Wei J, Liu X, Wu J, Xu W, Zhou J, Lu Z, Chen J, Guo F, Gao W, Li Q, Jiang K, Dai C, Miao Y. Modified One-layer Duct-to-mucosa Pancreaticojejunostomy Reduces Pancreatic Fistula After Pancreaticoduodenectomy. Int Surg. 2015 Jun 3. doi: 10.9738/INTSURG-D-15-00094.1. Online ahead of print.
- Derived from this study: PubMed 35289922Hai H, Li Z, Zhang Z, Cheng Y, Liu Z, Gong J, Deng Y. Duct-to-mucosa versus other types of pancreaticojejunostomy for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD013462. doi: 10.1002/14651858.CD013462.pub2.
- Individual participant dataSharing planned: No
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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.
Miao, Prof. study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified one-layer duct-to-mucosa Pancreaticojejunostomy and Invagination pancreaticojejunostomy in people with Pancreatic Fistula, run by Nanjing Medical University 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 6 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 26 Jul 2018. 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 Jishu Wei, M.D. (86-25-68136891, weijishu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically relevant postoperative pancreatic fistula (POPF) (time frame: Up to 60 days after Surgery). 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 NCT03600584, which also lists 2 linked publications.
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 26 Jul 2018.