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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 early oral intake | Experimental | early oral intake since postoperative day 1. |
|
| 2 jejunostomy tube feeding (JTF) | Experimental | jejunostomy tube feeding (JTF) was carried out after PD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early oral intake | Procedure | early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of Oral Intake | the amount of oral intake is recorded, including clear fluids, soft and solid food. | postoperative 1 to 7day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zheng chen, MD;PHD | Contact | 86-13809092636 | zhengchenseu@126.com | |
| wanli liu, MD | Contact | 86-527-84386319 | ltlwl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| zheng chen, MD;PHD | Xuzhou Medical University Affiliated Suqian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suqian Hospital | Suqian | Jiangsu | 223800 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24973198 | Background | 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. | |
| 25942488 | Background | 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. |
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| 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) |
|
postoperative 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 | serum albumin | postoperative 30d |
| weight | weight in kilograms | postoperative 30d |
| height | height in meters | postoperative 30d |
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| 25713805 | Background | 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. |
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| 16698152 | Background | 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. |
| 27160498 | Background | 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. |
| 26492489 | Background | 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. |
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