Pancreatic NeoplasmsNCT01695447
Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
A study testing duct-to-mucosa, invagination and Internal stent in people with Pancreatic Neoplasms and Biliary Tract Neoplasms, run by TingBo Liang at 1 site in China.
Trial summary
The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Neoplasms, Biliary Tract Neoplasms
- What is being tested?
- duct-to-mucosa, invagination and Internal stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2017
- 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
- Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
- 18 to 80 y/o
- Operation-tolerated
- Informed consent
Who cannot join
- History of gastrointestinal operation
- Pancreaticoduodenectomy is given up during operation
- Pancreatic duct is difficult to locate
- Patients require to exit from the study anytime
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
Hangzhou, Zhejiang, 310009
Ting-Bo Liang, Ph.D., M.D., +86 571 87783510, liangtingbo@zju.edu.cn
About this study
Official title: Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.
- Conditions
- Pancreatic Neoplasms, Biliary Tract Neoplasms
- Being tested
- duct-to-mucosa, invagination, Internal stent
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duct-to-mucosaProcedure or surgery
invaginationProcedure or surgery
Internal stentDevice
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| duct-to-mucosa | Experimental | duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy Receives: Procedure: duct-to-mucosa; Device: Internal stent |
| invagination | Active comparator | invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy Receives: Procedure: invagination; Device: Internal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic fistula
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
Measured: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
Secondary outcomes (4)
Mortality
30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the type of pancreaticojejunostomy
Measured: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Morbidity
any complications after operation will be recorded.
Measured: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Reoperation
Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
Measured: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Hospital stay
Post-operation hospital stay is assessed.
Measured: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TingBo Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695447
- Sponsor's protocol ID
- ZEH-LL-CX-004-02
- Status last verified
- Jan 2017
- First submitted
- 20 Sep 2012
- Last updated
- 26 Jan 2017
- Results posted
- No
Publications
Bai X, Zhang Q, Gao S, Lou J, Li G, Zhang Y, Ma T, Zhang Y, Xu Y, Liang T. Duct-to-Mucosa vs Invagination for Pancreaticojejunostomy after Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial from a Single Surgeon. J Am Coll Surg. 2016 Jan;222(1):10-8. doi: 10.1016/j.jamcollsurg.2015.10.003. Epub 2015 Oct 21.
PubMed 26577499
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01695447
- Acronym / sponsor ID
- ZEH-LL-CX-004-02
- Conditions
- Pancreatic Neoplasms, Biliary Tract Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TingBo LiangUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Sep 2012 (estimated)
- 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 purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| duct-to-mucosa | Experimental | Procedure: duct-to-mucosa, Device: Internal stentduct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy |
| invagination | Active comparator | Procedure: invagination, Device: Internal stentinvagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
- 18 to 80 y/o
- Operation-tolerated
- Informed consent
Key exclusion criteria (4 listed)
- History of gastrointestinal operation
- Pancreaticoduodenectomy is given up during operation
- Pancreatic duct is difficult to locate
- Patients require to exit from the study anytime
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 |
|---|---|---|
| duct-to-mucosa | Procedure or surgery | duct-to-mucosa |
| invagination | Procedure or surgery | invagination |
| Internal stentInternal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon. | Device | duct-to-mucosa, invagination |
Primary outcome
pancreatic fistula
Time frame: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
4 secondary outcomes
Mortality
Time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Morbidity
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Reoperation
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Hospital stay
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 26577499Bai X, Zhang Q, Gao S, Lou J, Li G, Zhang Y, Ma T, Zhang Y, Xu Y, Liang T. Duct-to-Mucosa vs Invagination for Pancreaticojejunostomy after Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial from a Single Surgeon. J Am Coll Surg. 2016 Jan;222(1):10-8. doi: 10.1016/j.jamcollsurg.2015.10.003. Epub 2015 Oct 21.
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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 duct-to-mucosa, invagination and Internal stent in people with Pancreatic Neoplasms and Biliary Tract Neoplasms, run by TingBo Liang 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 26 Jan 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 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 Xue-Li Bai, Ph.D. (+86 571 87783510, shirleybai57@hotmail.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: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days). 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 NCT01695447, which also lists 1 linked publication.
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 Jan 2017.