PancreatectomyNCT05297136
Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy
A study testing Pancreatic Stenting and No Stent in people with Pancreatectomy and Pancreatic Fistula, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Pancreatic Fistula
- What is being tested?
- Pancreatic Stenting and No Stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Mar 2022to 20 May 2026
- 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
- Age >18 years
- Elective distal pancreatectomy for primary pancreatic pathology
Who cannot join
- Informed consent not available
- Emergency distal pancreatectomy
- Presence of pancreatic duct stricture
- Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
- History of severe pancreatitis
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Kit Fai Lee, MBBS, 35051496, leekf@surgery.cuhk.edu.hk
About this study
Official title: Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial
Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.
Read the detailed description
A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.
- Conditions
- Pancreatectomy, Pancreatic Fistula
- Being tested
- Pancreatic Stenting, No Stent
- Keywords
- Distal Pancreatectomy, Pancreatic Fistula
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic StentingProcedure or surgery
Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
No StentProcedure or surgery
No preoperative stenting with distal pancreatectomy alone
| Study group | Role | What they receive |
|---|---|---|
| Pre-op Stenting | Experimental | Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy Receives: Procedure: Pancreatic Stenting |
| Surgery alone | Active comparator | Distal pancreatectomy alone Receives: Procedure: No Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative pancreatic fistula
The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3
Measured: Day 3 after operation
Secondary outcomes (4)
Number of participants developing post-operative morbidity
Post-operative complications, graded according to the Clavien-Dindo classification, are recorded
Measured: 90 days
Number of participants developing post-operative mortality
All cause mortality after operation was recorded
Measured: 90 days
Total length of hospital stay of participants
The total number of days spent in hospital calculated from the day of admission to discharge for every participant, including the time spent for pre-operative endoscopy and operation
Measured: 90 days after endoscopy and operation
Number of participants developing complications related to Endoscopic Retrograde Cholangiography
All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded
Measured: 14 days after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start21 Mar 2022
- Primary completion20 Mar 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Yue Sun, Chinese University of Hong Kong
- Investigators
- Kit Fai Lee, MBBS, Principal investigator, Clinical Associate Professor (honorary)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297136
- Sponsor's protocol ID
- 2021.728-T
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 28 Mar 2022
- 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 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05297136
- Acronym / sponsor ID
- 2021.728-T
- Conditions
- Pancreatectomy, Pancreatic Fistula
- Keywords
- Distal Pancreatectomy, Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 28 Mar 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.
Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.
Detailed description
A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-op Stenting | Experimental | Procedure: Pancreatic StentingPre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy |
| Surgery alone | Active comparator | Procedure: No StentDistal pancreatectomy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Elective distal pancreatectomy for primary pancreatic pathology
Key exclusion criteria (5 listed)
- Informed consent not available
- Emergency distal pancreatectomy
- Presence of pancreatic duct stricture
- Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
- History of severe pancreatitis
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 |
|---|---|---|
| Pancreatic StentingPancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy | Procedure or surgery | Pre-op Stenting |
| No StentNo preoperative stenting with distal pancreatectomy alone | Procedure or surgery | Surgery alone |
Primary outcome
Number of participants with postoperative pancreatic fistula
Time frame: Day 3 after operation
The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3
4 secondary outcomes
Number of participants developing post-operative morbidity
Time frame: 90 days
Number of participants developing post-operative mortality
Time frame: 90 days
Total length of hospital stay of participants
Time frame: 90 days after endoscopy and operation
Number of participants developing complications related to Endoscopic Retrograde Cholangiography
Time frame: 14 days after endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- 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.
Kit Fai Lee, MBBS principal investigator
Clinical Associate Professor (honorary)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic Stenting and No Stent in people with Pancreatectomy and Pancreatic Fistula, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 5 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 Mar 2022. 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 Hong Kong. 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 Kit Fai Lee, MBBS (35051496, leekf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative pancreatic fistula (time frame: Day 3 after operation). 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 Mar 2022.