NCT02941484

Brief Summary

Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. Specific clinical study on early oral intake after PD is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

October 16, 2016

Last Update Submit

October 20, 2016

Conditions

Periampullary Carcinoma ResectablePancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Tolerance of Oral Intake

    the amount of oral intake is recorded, including clear fluids, soft and solid food.

    postoperative 1 to 7day

Secondary Outcomes (7)

  • morbidity rate

    postoperative 1day to discharge, up to 8 weeks

  • length of stay

    postoperative 1day to discharge,up to 8 weeks

  • Readmission rate

    30 days after discharge

  • Hospital costs

    postoperative 1day to discharge,up to 8 weeks

  • Albumin

    postoperative 30d

  • +2 more secondary outcomes

Study Arms (2)

1 early oral intake

EXPERIMENTAL

early oral intake since postoperative day 1.

Procedure: early oral intake

2 jejunostomy tube feeding (JTF)

EXPERIMENTAL

jejunostomy tube feeding (JTF) was carried out after PD

Procedure: jejunostomy tube feeding (JTF)

Interventions

early oral intakePROCEDURE

early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline

1 early oral intake
jejunostomy tube feeding (JTF)PROCEDURE

The jejunostomy tube was placed using the Flocare CH-10 tube with the longitudinal Witzel jejunostomy technique.nutrition is supplemented via JTF rather than early oral intake.Velocity is progressively increased by 20ml/hr until full nutritional goal (25Kcal/Kg)

2 jejunostomy tube feeding (JTF)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Periampullar carcinoma
  • Pancreaticoduodenectomy
  • ERAS protocol implemented

You may not qualify if:

  • Preoperative Radiotherapy/chemotherapy
  • Unresectable primary cancer
  • Palliative surgery
  • New York Heart Association class\>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suqian Hospital

Suqian, Jiangsu, 223800, China

Location

Related Publications (15)

  • Bozzetti F, Mariani L. Perioperative nutritional support of patients undergoing pancreatic surgery in the age of ERAS. Nutrition. 2014 Nov-Dec;30(11-12):1267-71. doi: 10.1016/j.nut.2014.03.002. Epub 2014 Mar 14.

    PMID: 24973198BACKGROUND

  • Buscemi S, Damiano G, Palumbo VD, Spinelli G, Ficarella S, Lo Monte G, Marrazzo A, Lo Monte AI. Enteral nutrition in pancreaticoduodenectomy: a literature review. Nutrients. 2015 Apr 30;7(5):3154-65. doi: 10.3390/nu7053154.

    PMID: 25942488BACKGROUND

  • Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

    PMID: 12765673BACKGROUND

  • Afaneh C, Gerszberg D, Slattery E, Seres DS, Chabot JA, Kluger MD. Pancreatic cancer surgery and nutrition management: a review of the current literature. Hepatobiliary Surg Nutr. 2015 Feb;4(1):59-71. doi: 10.3978/j.issn.2304-3881.2014.08.07.

    PMID: 25713805BACKGROUND

  • Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available.

    PMID: 22956014BACKGROUND

  • Nussbaum DP, Penne K, Stinnett SS, Speicher PJ, Cocieru A, Blazer DG 3rd, Zani S, Clary BM, Tyler DS, White RR. A standardized care plan is associated with shorter hospital length of stay in patients undergoing pancreaticoduodenectomy. J Surg Res. 2015 Jan;193(1):237-45. doi: 10.1016/j.jss.2014.06.036. Epub 2014 Jun 26.

    PMID: 25062813BACKGROUND

  • Wei J, Chen W, Zhu M, Cao W, Wang X, Shi H, Dong B, Sun J, Chen H, Zhou Y, Zhou S, Xu J; Chinese Medical Association's Nutrition Support Group for Geriatric Patients. Guidelines for parenteral and enteral nutrition support in geriatric patients in China. Asia Pac J Clin Nutr. 2015;24(2):336-46. doi: 10.6133/apjcn.2015.24.2.11.

    PMID: 26078252BACKGROUND

  • Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P; DGEM (German Society for Nutritional Medicine); Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. Clin Nutr. 2006 Apr;25(2):224-44. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.

    PMID: 16698152BACKGROUND

  • Bounoure L, Gomes F, Stanga Z, Keller U, Meier R, Ballmer P, Fehr R, Mueller B, Genton L, Bertrand PC, Norman K, Henzen C, Laviano A, Bischoff S, Schneider SM, Kondrup J, Schuetz P; Members of the Working Group. Detection and treatment of medical inpatients with or at-risk of malnutrition: Suggested procedures based on validated guidelines. Nutrition. 2016 Jul-Aug;32(7-8):790-8. doi: 10.1016/j.nut.2016.01.019. Epub 2016 Feb 18.

    PMID: 27160498BACKGROUND

  • Joliat GR, Labgaa I, Petermann D, Hubner M, Griesser AC, Demartines N, Schafer M. Cost-benefit analysis of an enhanced recovery protocol for pancreaticoduodenectomy. Br J Surg. 2015 Dec;102(13):1676-83. doi: 10.1002/bjs.9957. Epub 2015 Oct 22.

    PMID: 26492489BACKGROUND

  • Coolsen MM, Bakens M, van Dam RM, Olde Damink SW, Dejong CH. Implementing an enhanced recovery program after pancreaticoduodenectomy in elderly patients: is it feasible? World J Surg. 2015 Jan;39(1):251-8. doi: 10.1007/s00268-014-2782-x.

    PMID: 25212064BACKGROUND

  • Chaudhary A, Barreto SG, Talole SD, Singh A, Perwaiz A, Singh T. Early discharge after pancreatoduodenectomy: what helps and what prevents? Pancreas. 2015 Mar;44(2):273-8. doi: 10.1097/MPA.0000000000000254.

    PMID: 25479587BACKGROUND

  • Bischoff SC, Singer P, Koller M, Barazzoni R, Cederholm T, van Gossum A. Standard operating procedures for ESPEN guidelines and consensus papers. Clin Nutr. 2015 Dec;34(6):1043-51. doi: 10.1016/j.clnu.2015.07.008. Epub 2015 Jul 16.

    PMID: 26254807BACKGROUND

  • Braga M, Pecorelli N, Ariotti R, Capretti G, Greco M, Balzano G, Castoldi R, Beretta L. Enhanced recovery after surgery pathway in patients undergoing pancreaticoduodenectomy. World J Surg. 2014 Nov;38(11):2960-6. doi: 10.1007/s00268-014-2653-5.

    PMID: 24870390BACKGROUND

  • Coolsen MM, van Dam RM, van der Wilt AA, Slim K, Lassen K, Dejong CH. Systematic review and meta-analysis of enhanced recovery after pancreatic surgery with particular emphasis on pancreaticoduodenectomies. World J Surg. 2013 Aug;37(8):1909-18. doi: 10.1007/s00268-013-2044-3.

    PMID: 23568250BACKGROUND

Study Officials

  • zheng chen, MD;PHD

    Xuzhou Medical University Affiliated Suqian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zheng chen, MD;PHD

CONTACT

86-13809092636zhengchenseu@126.com

wanli liu, MD

CONTACT

86-527-84386319ltlwl@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the director of general surgery;

Study Record Dates

First Submitted

October 16, 2016

First Posted

October 21, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

CN(1)