Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Pancreaticoduodenectomy Clinical Trial

Official title:

A Prospective, Randomized Trial of Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02941484
• Other study ID #: XuzhouMedSch
• Status: Not yet recruiting
• Phase: N/A
• First received: October 16, 2016
• Last updated: October 20, 2016
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Xuzhou Medical University
• Contact: zheng chen, MD;PHD
• Phone: 86-13809092636
• Email: zhengchenseu[@]126.com
• Is FDA regulated: No
• Health authority: china: Suqian Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Description:

Enhanced Recovery After Surgery (ERAS) is an interdisciplinary, multimodal concept and has become an important focus of Pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. Early oral diet without restrictions after operation is recommended strongly according to ERAS guideline. However, several studies demonstrated that only half validated the true practice of the postoperative oral diet. Furthermore, Oral intake tolerance after PD is controversial. Only 23% of patients were able to take solid food at day 3. It appears that adequate nutritional intake only via oral diet is a severe challenge. Besides, Studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. Importantly, Specific clinical study on early oral intake after PD is very limited. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Periampullar carcinoma

• Pancreaticoduodenectomy

• ERAS protocol implemented

Exclusion Criteria:

• Preoperative Radiotherapy/chemotherapy

• Unresectable primary cancer

• Palliative surgery

• New York Heart Association class>3

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreaticoduodenectomy
• Periampullary Carcinoma Resectable

Intervention

Procedure:
• early oral intake
early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline
• jejunostomy tube feeding (JTF)
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)

Locations

Country	Name	City	State
China	Suqian Hospital	Suqian	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Xuzhou Medical University	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (15)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Joliat GR, Labgaa I, Petermann D, Hübner M, Griesser AC, Demartines N, Schäfer 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. — View Citation

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. — View Citation

Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer 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®) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 May 15. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of Oral Intake	the amount of oral intake is recorded, including clear fluids, soft and solid food.	postoperative 1 to 7day	Yes
Secondary	morbidity rate	complications associated with surgery, early oral intake,and jejunostomy tube.Definitions used for specific complications are according to the International Study Group on Pancreatic Fistula (ISGPF) definition.	postoperative 1day to discharge, up to 8 weeks	No
Secondary	length of stay	postoperative length of stay	postoperative 1day to discharge,up to 8 weeks	No
Secondary	Readmission rate		30 days after discharge	No
Secondary	Hospital costs		postoperative 1day to discharge,up to 8 weeks	No
Secondary	Albumin	serum albumin	postoperative 30d	No
Secondary	weight	weight in kilograms	postoperative 30d	No
Secondary	height	height in meters	postoperative 30d	No