Pancreatic FistulaNCT03201653
A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
A study testing Stump closure using NU-KNIT SURGICEL in people with Pancreatic Fistula, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to 60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP (12% to 40%). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Stump closure using NU-KNIT SURGICEL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2017to Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>= 20 years
- scheduled distal pancreatectomy at NTUH
- unable to realize this trial and willing to sign the informed consent form
Who cannot join
- age< 20 years, pregnent women, breast-feeding women, or mentally illed
- active malignancy within 2 years
- received other upper abdomen major surgery
- scheduled spleen preservation or associated major organ resection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
Yu-Wen Tien, PhD, +886-2-23123456 ext. 65083, ywtien5106@ntu.edu.tw
Ting-Chun Kuo, MD, +886-2-23123456 ext. 63746, tina@ntuh.gov.tw
About this study
Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to 60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP (12% to 40%). POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem. However, all the previous reports were retrospective review, non-randomized study, or individual experience and showed no significant improvement of overall POPF. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.
Read the detailed description
Pancreatic surgery has been called formidable operation not only the technical challenge to surgeons but also demanding for patients. It evolved into a safe procedure with mortality rates of <5% recently, cutting down gradually from 25% in the 1960s. However, overall morbidity rate remained high ranging from 30% to 60%.
Distal pancreatectomy (DP) has been believed a safer and minor procedure compared with pancreatic head resection including standard pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), or duodenum-preserving pancreatic head resection (DPPHR). Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP. Büchler et al observed that the POPF rate was in fact significantly higher after DP when compared to pancreatic head resections. The variable documented incidence of POPF following DP ranges from 12% to 40%. POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem.
Although the majority of complications are not life-threatening, POPF could prolong hospitalization, expend expenditure for healthcare, abrade the quality of life; moreover, delay in further management for a fraction of patients with malignancy. Over the past two decades, various risk factors and multitudinous operative procedures have been held for reduction POPD following DP. These include underlying disease process, method of stump closure, and concomitant splenectomy However, all these reports were retrospective review, non-randomized study, or individual experience. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.
- Conditions
- Pancreatic Fistula
- Being tested
- Stump closure using NU-KNIT SURGICEL
- Keywords
- Distal Pancreatectomy, Pancreatic Fistula, Oxidized Regenerated Cellulose, Pancreatectomy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stump closure using NU-KNIT SURGICELProcedure or surgery
Also called SURGICEL (Oxidized Regenerated Cellulose)
We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures. Receives: Procedure: Stump closure using NU-KNIT SURGICEL |
| Surgicel | Experimental | Stump closure modified from our institute routine, using interrupted silk mattress suture and continuous prolene sutures with NU-KNIT SURGICEL overlying for reinforcement. Receives: Procedure: Stump closure using NU-KNIT SURGICEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
POPF rate
The percentage of overall (grade A, B, C) POPF.
Measured: through study completion, an average of 16 days
Secondary outcomes (4)
Duration of drainage replacement
Duration of drainage replacement after DP
Measured: through study completion, an average of 16 days
Hospitalization
Duration of hospital stay after DP
Measured: through study completion, an average of 16 days
Hospitalization cost
Total hospital cost of for DP
Measured: through study completion, an average of 16 days
Mortality
Procedure-related mortality after DP
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 posted28 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (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 National Taiwan University HospitalThe 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
- Model description
- SURGICEL group comparisons to traditional group (each performed at a nominal alpha of 0.05 and power of 0.80) in a 2:1 allocation ratio
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201653
- Sponsor's protocol ID
- 201507019RIND
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT03201653
- Acronym / sponsor ID
- 201507019RIND
- Conditions
- Pancreatic Fistula
- Keywords
- Distal Pancreatectomy, Pancreatic Fistula, Oxidized Regenerated Cellulose, Pancreatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Jun 2017 (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.
Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to 60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP (12% to 40%). POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem. However, all the previous reports were retrospective review, non-randomized study, or individual experience and showed no significant improvement of overall POPF. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.
Detailed description
Pancreatic surgery has been called formidable operation not only the technical challenge to surgeons but also demanding for patients. It evolved into a safe procedure with mortality rates of <5% recently, cutting down gradually from 25% in the 1960s. However, overall morbidity rate remained high ranging from 30% to 60%.
Distal pancreatectomy (DP) has been believed a safer and minor procedure compared with pancreatic head resection including standard pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), or duodenum-preserving pancreatic head resection (DPPHR). Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP. Büchler et al observed that the POPF rate was in fact significantly higher after DP when compared to pancreatic head resections. The variable documented incidence of POPF following DP ranges from 12% to 40%. POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem.
Although the majority of complications are not life-threatening, POPF could prolong hospitalization, expend expenditure for healthcare, abrade the quality of life; moreover, delay in further management for a fraction of patients with malignancy. Over the past two decades, various risk factors and multitudinous operative procedures have been held for reduction POPD following DP. These include underlying disease process, method of stump closure, and concomitant splenectomy However, all these reports were retrospective review, non-randomized study, or individual experience. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- SURGICEL group comparisons to traditional group (each performed at a nominal alpha of 0.05 and power of 0.80) in a 2:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Stump closure using NU-KNIT SURGICELStump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures. |
| Surgicel | Experimental | Procedure: Stump closure using NU-KNIT SURGICELStump closure modified from our institute routine, using interrupted silk mattress suture and continuous prolene sutures with NU-KNIT SURGICEL overlying for reinforcement. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age>= 20 years
- scheduled distal pancreatectomy at NTUH
- unable to realize this trial and willing to sign the informed consent form
Key exclusion criteria (4 listed)
- age< 20 years, pregnent women, breast-feeding women, or mentally illed
- active malignancy within 2 years
- received other upper abdomen major surgery
- scheduled spleen preservation or associated major organ resection
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 |
|---|---|---|
| Stump closure using NU-KNIT SURGICELAlso: SURGICEL (Oxidized Regenerated Cellulose)We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL. | Procedure or surgery | Conventional, Surgicel |
Primary outcome
POPF rate
Time frame: through study completion, an average of 16 days
The percentage of overall (grade A, B, C) POPF.
4 secondary outcomes
Duration of drainage replacement
Time frame: through study completion, an average of 16 days
Hospitalization
Time frame: through study completion, an average of 16 days
Hospitalization cost
Time frame: through study completion, an average of 16 days
Mortality
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 28 Jun 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stump closure using NU-KNIT SURGICEL in people with Pancreatic Fistula, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 28 Jun 2017. 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 Taiwan. 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 Ting-Chun Kuo, MD (+886-2-23123456 ext. 63746, tina@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POPF rate (time frame: through study completion, an average of 16 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 28 Jun 2017.