Esophagus CancerNCT01669356
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
A study testing Parenteral supplement with enteral nutrition for patients after esophagectomy and Enteral Nutrition alone for patients after esophagectomy in people with Esophagus Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Parenteral supplement with enteral nutrition for patients after esophagectomy and Enteral Nutrition alone for patients after esophagectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Mar 2014
- 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
- Clinical diagnosis of esophagus cancer
- Undergo esophagectomy
- Nasoenteral tube is placed or surgical jejunostomy is performed
Who cannot join
- Contraindication for enteral nutrition or parenteral nutrition
- Malnutrition before surgery ( BMI > 30 or < 18.5)
- Hepatic dysfunction preoperatively
- Renal dysfunction preoperatively
- Infection before surgery
- Usage of corticosteroid before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial
Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.
- Conditions
- Esophagus Cancer
- Being tested
- Parenteral supplement with enteral nutrition for patients after esophagectomy, Enteral Nutrition alone for patients after esophagectomy
- Keywords
- malnutrition, parenteral supplement, rest metabolic rate, postoperative complications
- Medical subject headings
- Esophageal Neoplasms, Malnutrition, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral supplement with enteral nutrition for patients after esophagectomyOther
Enteral Nutrition alone for patients after esophagectomyOther
| Study group | Role | What they receive |
|---|---|---|
| PN supplement | Experimental | Parenteral supplement with enteral nutrition for patients after esophagectomy Receives: Other: Parenteral supplement with enteral nutrition for patients after esophagectomy |
| EN alone | Active comparator | Enteral nutrition alone for patients after esophagectomy Receives: Other: Enteral Nutrition alone for patients after esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative laboratory parameters changes for nutrition assessment compared to preoperation
plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts
Measured: from one day before surgery to the 7th postoperative day
postoperative body composition change compared to preoperation measurement
postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition
Measured: from one day before surgery to the 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionMar 2014
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 Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669356
- Sponsor's protocol ID
- PNsupplESO
- Other IDs
- Energy Supply Trial
- Status last verified
- Mar 2014
- First submitted
- 11 Aug 2012
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu W, Zhong M, Zhu DM, Song JQ, Huang JF, Wang Q, Tan LJ. Effect of Early Full-Calorie Nutrition Support Following Esophagectomy: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1146-1154. doi: 10.1177/0148607116651509. Epub 2016 May 20.
PubMed 27208039
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01669356
- Acronym / sponsor ID
- PNsupplESO
- Conditions
- Esophagus Cancer
- Keywords
- malnutrition, parenteral supplement, rest metabolic rate, postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Aug 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.
Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PN supplement | Experimental | Other: Parenteral supplement with enteral nutrition for patients after esophagectomyParenteral supplement with enteral nutrition for patients after esophagectomy |
| EN alone | Active comparator | Other: Enteral Nutrition alone for patients after esophagectomyEnteral nutrition alone for patients after esophagectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of esophagus cancer
- Undergo esophagectomy
- Nasoenteral tube is placed or surgical jejunostomy is performed
Key exclusion criteria (6 listed)
- Contraindication for enteral nutrition or parenteral nutrition
- Malnutrition before surgery ( BMI > 30 or < 18.5)
- Hepatic dysfunction preoperatively
- Renal dysfunction preoperatively
- Infection before 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 |
|---|---|---|
| Parenteral supplement with enteral nutrition for patients after esophagectomy | Other | PN supplement |
| Enteral Nutrition alone for patients after esophagectomy | Other | EN alone |
Primary outcome
postoperative laboratory parameters changes for nutrition assessment compared to preoperation
Time frame: from one day before surgery to the 7th postoperative day
plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts
postoperative body composition change compared to preoperation measurement
Time frame: from one day before surgery to the 7th postoperative day
postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition
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 1 Apr 2014.
- Derived from this study: PubMed 27208039Wu W, Zhong M, Zhu DM, Song JQ, Huang JF, Wang Q, Tan LJ. Effect of Early Full-Calorie Nutrition Support Following Esophagectomy: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1146-1154. doi: 10.1177/0148607116651509. Epub 2016 May 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral supplement with enteral nutrition for patients after esophagectomy and Enteral Nutrition alone for patients after esophagectomy in people with Esophagus Cancer, run by Shanghai Zhongshan Hospital 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 3 inclusion and 6 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 1 Apr 2014. 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?
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?
postoperative laboratory parameters changes for nutrition assessment compared to preoperation (time frame: from one day before surgery to the 7th postoperative day). The study lists 2 primary outcomes in all. 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 NCT01669356, 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 1 Apr 2014.