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Cancer of PancreasNCT03150615

Enteral Nutrition After Pancreaticoduodenectomy

A study testing Early enteral nutrition, Saline and nasojejunal tube insertion in people with Cancer of Pancreas and Cancer of Duodenum, run by Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Early enteral nutrition, Saline and nasojejunal tube insertion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
Sep 2016to Feb 2018
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 underwent selective pancreaticoduodenectomy Patients ≥18 years old and ≤80 years old Having given written informed consent

Who cannot join

  • Previous gastric resection or intestinal reconstruction Preoperative complete parenteral or enteral feeding ASA score ≥4 Pregnant women Severe malnutrition Patient who cannot give written informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first affiliated hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition.

Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.

Being tested
Early enteral nutrition, Saline, nasojejunal tube insertion, Oral intake
Medical subject headings
Pancreatic Neoplasms, Duodenal Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early enteral nutritionOther

    Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. Standard enteral diet, administered through a nasojejunal tube, is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.

    After PD, enteral nutrition liquid regimen will be used step by step from postoperative day 1 to postoperative day 7.Patients are targeted to receive calories for 25 kcal/kg/day. Meanwhile, oral food intake was not restricted.

  • SalineOther

    Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament.

    After PPPD,Only Normal Saline were given through nasojejunal tube. Entral nutrition was not administrated. Patients intake food orally at will.

  • nasojejunal tube insertionDevice

    Also called Naso-jejunal tube will be placed intraoperatively.

  • Oral intakeOther

    Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.

Study groups in NCT03150615
Study groupRoleWhat they receive
Early enteral nutritionExperimentalNasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Receives: Other: Early enteral nutrition; Device: nasojejunal tube insertion; Other: Oral intake
Saline GroupPlacebo comparatorNasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Receives: Other: Saline; Device: nasojejunal tube insertion
ERAS GroupOtherNasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Receives: Device: nasojejunal tube insertion; Other: Oral intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incident rate of delayed gastric emptying

    DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.

    Measured: 30 days

Secondary outcomes (9)

  1. Postoperative hospital stay length

    Measured: 60 days

  2. Overall morbidity rate

    Measured: 30 days

  3. Postoperative mortality rate

    Measured: 30 days

  4. Rehospitalization rate

    Measured: 60 days

  5. Infectious complications

    Measured: 30 days

  6. Evaluation of the severity of the complications

    according to classification of Dindo-Clavien

    Measured: 30 days

  7. Pancreatic fistulas

    evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients

    Measured: 30 days

  8. Hemorrhagic complications

    evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients

    Measured: 30 days

  9. Maximum Plasma Concentration fasting plasma GLP-1 level

    Fasting plasma concentration GLP-1 level was monitored

    Measured: Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study startSep 2016
  3. Primary completionDec 2017
  4. Study completionFeb 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150615
Sponsor's protocol ID
NMU-JSPH-PC-Nutrition
Status last verified
Jul 2019
First submitted
26 Mar 2017
Last updated
12 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • Shen Y, Jin W. Early enteral nutrition after pancreatoduodenectomy: a meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2013 Aug;398(6):817-23. doi: 10.1007/s00423-013-1089-y. Epub 2013 May 22.

    PubMed 23695769

  • Lu JW, Liu C, Du ZQ, Liu XM, Lv Y, Zhang XF. Early enteral nutrition vs parenteral nutrition following pancreaticoduodenectomy: Experience from a single center. World J Gastroenterol. 2016 Apr 14;22(14):3821-8. doi: 10.3748/wjg.v22.i14.3821.

    PubMed 27076767

  • Zhu XH, Wu YF, Qiu YD, Jiang CP, Ding YT. Effect of early enteral combined with parenteral nutrition in patients undergoing pancreaticoduodenectomy. World J Gastroenterol. 2013 Sep 21;19(35):5889-96. doi: 10.3748/wjg.v19.i35.5889.

    PubMed 24124335

  • Perinel J, Mariette C, Dousset B, Sielezneff I, Gainant A, Mabrut JY, Bin-Dorel S, Bechwaty ME, Delaunay D, Bernard L, Sauvanet A, Pocard M, Buc E, Adham M. Early Enteral Versus Total Parenteral Nutrition in Patients Undergoing Pancreaticoduodenectomy: A Randomized Multicenter Controlled Trial (Nutri-DPC). Ann Surg. 2016 Nov;264(5):731-737. doi: 10.1097/SLA.0000000000001896.

    PubMed 27429039

  • Rayar M, Sulpice L, Meunier B, Boudjema K. Enteral nutrition reduces delayed gastric emptying after standard pancreaticoduodenectomy with child reconstruction. J Gastrointest Surg. 2012 May;16(5):1004-11. doi: 10.1007/s11605-012-1821-x. Epub 2012 Jan 19.

    PubMed 22258876

  • Liu X, Chen Q, Fu Y, Lu Z, Chen J, Guo F, Li Q, Wu J, Gao W, Jiang K, Dai C, Miao Y, Wei J. Early Nasojejunal Nutrition Versus Early Oral Feeding in Patients After Pancreaticoduodenectomy: A Randomized Controlled Trial. Front Oncol. 2021 Apr 29;11:656332. doi: 10.3389/fonc.2021.656332. eCollection 2021.

    PubMed 33996579

Questions about this trial

What is this clinical trial studying?

A study testing Early enteral nutrition, Saline and nasojejunal tube insertion in people with Cancer of Pancreas and Cancer of Duodenum, run by Nanjing Medical University 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 1 inclusion and 1 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 12 Jul 2019. 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. Some participants in this study may receive a placebo. 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?

Incident rate of delayed gastric emptying (time frame: 30 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 NCT03150615, which also lists 6 linked publications.

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 12 Jul 2019.

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