Pancreas CancerPhase 3NCT00809081
Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
A Phase 3 study testing Enteral Feeding and Total Parental Support in people with Pancreas Cancer and Bile Duct Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- What is being tested?
- Enteral Feeding and Total Parental Support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Jan 2010
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periampullar carcinoma
- Pancreaticoduonectomy
- KARNOFSKY PERFORMANCE SCALE > 70
- No history of Major operation
Who cannot join
- Creatinine level>3mg/L
- Ascitis/portal hypertension
- New York Heart Association class>3
- COPD
- Preoperative Radiotheraly/chemotherapy
- Unresectable primary cancer
- Palliative surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yongdong Severance Hospital
Seoul
Dong Sup Yoon, MD, PhD, +82-2-2019-2444, yds6110@yuhs.ac
Joon Seong Park, MD, +82-2-2019-3375, jspark330@yuhs.ac
About this study
Official title: A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
- To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
- To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
Read the detailed description
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
- To evaluate whether early enteral nutrition may be decreased the postoperative complications
- To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
- To determine the optimal method for postoperative nutritional support
- Conditions
- Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Being tested
- Enteral Feeding and Total Parental Support
- Keywords
- periampullar carcinoma, Pancreaticoduodenectomy, Enteral feeding, Total Parenteral Support
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Feeding and Total Parental SupportProcedure or surgery
Also called Total Parental support: 1000 kcal /d on POD 1, : Velocity is progressively increased by 20ml/d, until full nutritional goal (25Kcal/Kg)
Enteral Feeding : 20ml/hr on POD1
- Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 1. Enteral Feeding Receives: Procedure: Enteral Feeding and Total Parental Support |
| 2 | No intervention | Total Parental support Receives: Procedure: Enteral Feeding and Total Parental Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of early postoperative enteral feeding
Measured: Postoperative 21 days
Secondary outcomes (1)
To evaluate the nutritional status
Measured: Postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Dong Sup Yoon, MD,PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809081
- Sponsor's protocol ID
- EN Vs PN
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT00809081
- Acronym / sponsor ID
- EN Vs PN
- Conditions
- Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Keywords
- periampullar carcinoma, Pancreaticoduodenectomy, Enteral feeding, Total Parenteral Support
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 16 Dec 2008 (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.
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
- To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
- To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
Detailed description
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
- To evaluate whether early enteral nutrition may be decreased the postoperative complications
- To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
- To determine the optimal method for postoperative nutritional support
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Enteral Feeding and Total Parental Support1. Enteral Feeding |
| 2 | No intervention | Procedure: Enteral Feeding and Total Parental SupportTotal Parental support |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Periampullar carcinoma
- Pancreaticoduonectomy
- KARNOFSKY PERFORMANCE SCALE > 70
- No history of Major operation
Key exclusion criteria (7 listed)
- Creatinine level>3mg/L
- Ascitis/portal hypertension
- New York Heart Association class>3
- COPD
- Preoperative Radiotheraly/chemotherapy
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 |
|---|---|---|
| Enteral Feeding and Total Parental SupportAlso: Total Parental support: 1000 kcal /d on POD 1, : Velocity is progressively increased by 20ml/d, until full nutritional goal (25Kcal/Kg)Enteral Feeding : 20ml/hr on POD1 * Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg) | Procedure or surgery | 1, 2 |
Primary outcome
To evaluate the impact of early postoperative enteral feeding
Time frame: Postoperative 21 days
1 secondary outcome
To evaluate the nutritional status
Time frame: Postoperative 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
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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.
Dong Sup Yoon, MD,PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enteral Feeding and Total Parental Support in people with Pancreas Cancer and Bile Duct Cancer, run by Yonsei University at 1 site in South Korea.
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 7 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 16 Dec 2008. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of early postoperative enteral feeding (time frame: Postoperative 21 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 16 Dec 2008.