Delayed Gastric EmptyingQUANUPADNCT03984734
Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy
A study testing Pancreatoduodenectomy with antrectomy and Pylorus-preserving pancreatoduodenectomy in people with Delayed Gastric Emptying, run by Hospital Universitari de Bellvitge.
Trial summary
This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Gastric Emptying
- What is being tested?
- Pancreatoduodenectomy with antrectomy and Pylorus-preserving pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2008
- 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
- Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included.
Who cannot join
- Associated resections of other organs, except for the portal or superior mesenteric vein
- Total pancreatectomy
- Previous gastrectomy or other gastric surgeries
- Neoadjuvant treatment
- Liver cirrhosis.
About this study
Official title: Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.
Read the detailed description
This was a randomized unblinded single-centre trial without masked evaluation of the main outcome.The authors decided to compare pancreatoduodenectomy with antrectomy versus pancreatoduodenectomy with pyloric preservation. The primary aim of this randomized clinical trial was to determine whether pancreatoduodenectomy with pyloric preservation is associated with a lower incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative complications, postoperative mortality and duration of hospital stay. Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction. Analytical parameters such as C-reactive protein, prealbumin, and albumin; as well as anthropometric measures (mean) as preoperative arm circumference mean and tricipital skinfold mean were registered preoperatively, at 5th week, and at 6th mounth. Scintigraphic study had performed following a specific protocol for gastric emptying. At the end, quality of life was also analized with a quality of life questionnaire (QLPAN26) preoperativelly and postoperatively.
- Conditions
- Delayed Gastric Emptying
- Being tested
- Pancreatoduodenectomy with antrectomy, Pylorus-preserving pancreatoduodenectomy
- Keywords
- Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatoduodenectomy with antrectomyProcedure or surgery
Pylorus-preserving pancreatoduodenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients undergoing pancreatoduodenectomy with antrectomy Receives: Procedure: Pancreatoduodenectomy with antrectomy |
| Study group | Experimental | Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy Receives: Procedure: Pylorus-preserving pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of DGE
Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day
Measured: within the first 90 days after surgery
Secondary outcomes (3)
Postoperative morbidity
Appearance of any complication during the hospital stay
Measured: within the first 90 days after surgery
Postoperative mortality
Any death that happens during the hospital admission or within 90 days after surgery
Measured: within the first 90 days after surgery
Length of hospital stay
Postoperative hospital stay after pancreatoduodenectomy
Measured: within the first 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 posted13 Jun 2019
- Study startAug 2003
- Primary completionAug 2008
- Study completionAug 2008
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 Delayed Gastric EmptyingStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BUSQUETS, JULI, Hospital Universitari de Bellvitge
- Investigators
- Juan Fabregat Prous, Dr., Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984734
- Sponsor's protocol ID
- QUANUPAD
- Acronym
- QUANUPAD
- Status last verified
- Jun 2019
- First submitted
- 25 Mar 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Busquets J, Martin S, Secanella L, Sorribas M, Cornella N, Altet J, Pelaez N, Bajen M, Carnaval T, Videla S, Fabregat J. Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD). Langenbecks Arch Surg. 2022 Sep;407(6):2247-2258. doi: 10.1007/s00423-022-02583-9. Epub 2022 Jul 4.
PubMed 35786739
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
- ClinicalTrials.gov ID
- NCT03984734
- Acronym / sponsor ID
- QUANUPAD / QUANUPAD
- Conditions
- Delayed Gastric Emptying
- Keywords
- Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Aug 2003 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Jun 2019 (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.
This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.
Detailed description
This was a randomized unblinded single-centre trial without masked evaluation of the main outcome.The authors decided to compare pancreatoduodenectomy with antrectomy versus pancreatoduodenectomy with pyloric preservation. The primary aim of this randomized clinical trial was to determine whether pancreatoduodenectomy with pyloric preservation is associated with a lower incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative complications, postoperative mortality and duration of hospital stay. Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction. Analytical parameters such as C-reactive protein, prealbumin, and albumin; as well as anthropometric measures (mean) as preoperative arm circumference mean and tricipital skinfold mean were registered preoperatively, at 5th week, and at 6th mounth. Scintigraphic study had performed following a specific protocol for gastric emptying. At the end, quality of life was also analized with a quality of life questionnaire (QLPAN26) preoperativelly and postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Pancreatoduodenectomy with antrectomyPatients undergoing pancreatoduodenectomy with antrectomy |
| Study group | Experimental | Procedure: Pylorus-preserving pancreatoduodenectomyPatients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included.
Key exclusion criteria (5 listed)
- Associated resections of other organs, except for the portal or superior mesenteric vein
- Total pancreatectomy
- Previous gastrectomy or other gastric surgeries
- Neoadjuvant treatment
- Liver cirrhosis.
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 |
|---|---|---|
| Pancreatoduodenectomy with antrectomy | Procedure or surgery | Control group |
| Pylorus-preserving pancreatoduodenectomy | Procedure or surgery | Study group |
Primary outcome
Incidence and severity of DGE
Time frame: within the first 90 days after surgery
Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day
3 secondary outcomes
Postoperative morbidity
Time frame: within the first 90 days after surgery
Postoperative mortality
Time frame: within the first 90 days after surgery
Length of hospital stay
Time frame: within the first 90 days 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 13 Jun 2019.
- Derived from this study: PubMed 35786739Busquets J, Martin S, Secanella L, Sorribas M, Cornella N, Altet J, Pelaez N, Bajen M, Carnaval T, Videla S, Fabregat J. Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD). Langenbecks Arch Surg. 2022 Sep;407(6):2247-2258. doi: 10.1007/s00423-022-02583-9. Epub 2022 Jul 4.
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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.
Juan Fabregat Prous, Dr. principal investigator
Hospital Universitari de Bellvitge
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatoduodenectomy with antrectomy and Pylorus-preserving pancreatoduodenectomy in people with Delayed Gastric Emptying, run by Hospital Universitari de Bellvitge.
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 1 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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 and severity of DGE (time frame: within the first 90 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 NCT03984734, 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 13 Jun 2019.