PancreatoduodenectomyNCT01984216
Billroth II Versus Roux-en-Y for the Gastrojejunostomy in the Pancreatoduodenectomy
A study testing Roux-en-Y for the gastrojejunostomy reconstruction and Billroth II for the gastrojejunostomy reconstruction in people with Pancreatoduodenectomy, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatoduodenectomy
- What is being tested?
- Roux-en-Y for the gastrojejunostomy reconstruction and Billroth II for the gastrojejunostomy reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Aug 2016
- 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
- Consecutive series of patients undergoing pancreaticoduodenectomy (PD).
- Given informed consent.
Who cannot join
- Inability to perform pancreatogastrostomy.
- Resection of other organs, except the superior mesenteric-portal vein.
- Previous gastric surgery.
- Preoperative gastric or duodenal obstruction.
- Previous complex abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Billroth II Versus Roux-en-Y for the Gastrojejunostomy Reconstruction in the Pancreatoduodenectomy: a Randomized Controlled Study
The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.
- Conditions
- Pancreatoduodenectomy
- Being tested
- Roux-en-Y for the gastrojejunostomy reconstruction, Billroth II for the gastrojejunostomy reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y for the gastrojejunostomy reconstructionProcedure or surgery
Billroth II for the gastrojejunostomy reconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y | Experimental | Roux-en-Y for the gastrojejunostomy reconstruction Receives: Procedure: Roux-en-Y for the gastrojejunostomy reconstruction |
| Billroth II | Active comparator | Billroth II for the gastrojejunostomy reconstruction Receives: Procedure: Billroth II for the gastrojejunostomy reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed gastric emptying (DGE)
Measured: 30 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatoduodenectomyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Herrera, MD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984216
- Sponsor's protocol ID
- CIRUGIA-CHN
- Other IDs
- 2013-000693-30
- Status last verified
- Aug 2016
- First submitted
- 7 Nov 2013
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Billroth II Versus Roux-en-Y for the Gastrojejunostomy Reconstruction in the Pancreatoduodenectomy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01984216
- Acronym / sponsor ID
- CIRUGIA-CHN
- Conditions
- Pancreatoduodenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Nov 2013 (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 compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y | Experimental | Procedure: Roux-en-Y for the gastrojejunostomy reconstructionRoux-en-Y for the gastrojejunostomy reconstruction |
| Billroth II | Active comparator | Procedure: Billroth II for the gastrojejunostomy reconstructionBillroth II for the gastrojejunostomy reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive series of patients undergoing pancreaticoduodenectomy (PD).
- Given informed consent.
Key exclusion criteria (5 listed)
- Inability to perform pancreatogastrostomy.
- Resection of other organs, except the superior mesenteric-portal vein.
- Previous gastric surgery.
- Preoperative gastric or duodenal obstruction.
- Previous complex abdominal surgery.
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 |
|---|---|---|
| Roux-en-Y for the gastrojejunostomy reconstruction | Procedure or surgery | Roux-en-Y |
| Billroth II for the gastrojejunostomy reconstruction | Procedure or surgery | Billroth II |
Primary outcome
Incidence of delayed gastric emptying (DGE)
Time frame: 30 day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Navarrabiomed: the biomedical research branch of Complejo Hospitalario de NavarraLink provided by the sponsor.
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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.
Francisco Javier Herrera, MD principal investigator
Complejo Hospitalario de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y for the gastrojejunostomy reconstruction and Billroth II for the gastrojejunostomy reconstruction in people with Pancreatoduodenectomy, run by Fundacion Miguel Servet at 1 site in Spain.
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: finished, as of the sponsor's last update on 29 Aug 2016. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed gastric emptying (DGE) (time frame: 30 day after surgery). 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 29 Aug 2016.