The Effect of ERAS on Pancreaticoduodenectomy

Periampullary Tumor Clinical Trial

— ERAS  

Official title:

The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372331
• Other study ID #: ERAS
• Status: Completed
• Phase: N/A
• First received: February 12, 2015
• Last updated: June 8, 2017
• Start date: March 4, 2015
• Est. completion date: May 26, 2017

Study information

• Verified date: June 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

This study investigate the clinical effectiveness of ERAS on PD.

Description:

• This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.

• The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.

• Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.

• Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: May 26, 2017
• Est. primary completion date: May 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• >18 years old or <75 years old

• ECOG 0-2

• resectable periampullary cancer or borderline malignancy

• no distant metastasis

• no functional disturbance in bone marrow; WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3

• no functional disturtance in liver; Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal

• no function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal

• informed consent

Exclusion Criteria:

• distant metastasis (+) or recurred periampullary tumor

• active or uncontrolled infection

• uncontrolled psychiatric or neurologic problems

• alcohol or other drug addiction

• already enrolled patient in other study which affect this study

• the patient who is impossible to allow investigator's order

• pregnant or the possibility of pregnancy (+)

• uncontrolled cardiopulmonary disease

• moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.)

• previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.)

• in preoperative period, expected combined resection of other gastrointestinal organ including portal vein

Related Conditions & MeSH terms

• Periampullary Tumor

Intervention

Other:
• ERAS perioperative management
Preop Counseling Preop biliary drainage (X) when Serum Total bilirubin < 14.62mg/dl and cholangitis (-) Preop enteral nutrition Oral bowel preparation (mechanical bowel preparation ) (X) Preop fasting < 6 hours Prevention of postoperative nausea and vomiting (PONV) (O) Nasogastric intubation (X) Near-zero fluid balance Somatostatin analogues (X) Postop routine artificial nutrition (X), soft diet at POD #2 Audit Other items are same as conventional

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

American Society of Anesthesiologists Committee.. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. — View Citation

Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324. — View Citation

Berberat PO, Ingold H, Gulbinas A, Kleeff J, Müller MW, Gutt C, Weigand M, Friess H, Büchler MW. Fast track--different implications in pancreatic surgery. J Gastrointest Surg. 2007 Jul;11(7):880-7. — View Citation

di Sebastiano P, Festa L, De Bonis A, Ciuffreda A, Valvano MR, Andriulli A, di Mola FF. A modified fast-track program for pancreatic surgery: a prospective single-center experience. Langenbecks Arch Surg. 2011 Mar;396(3):345-51. doi: 10.1007/s00423-010-0707-1. Epub 2010 Aug 12. — View Citation

Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. Epub 2005 Apr 21. Review. — View Citation

Kennedy EP, Rosato EL, Sauter PK, Rosenberg LM, Doria C, Marino IR, Chojnacki KA, Berger AC, Yeo CJ. Initiation of a critical pathway for pancreaticoduodenectomy at an academic institution--the first step in multidisciplinary team building. J Am Coll Surg. 2007 May;204(5):917-23; discussion 923-4. — 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

Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group.. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170. Review. — View Citation

Stergiopoulou A, Birbas K, Katostaras T, Mantas J. The effect of interactive multimedia on preoperative knowledge and postoperative recovery of patients undergoing laparoscopic cholecystectomy. Methods Inf Med. 2007;46(4):406-9. — View Citation

Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	The incidence of operation-related morbidity	3 months
Secondary	Mortality	The incidence of 30 days mortality and in-hospital mortality	3 months
Secondary	length of stay	postoperative length of stay	3 months
Secondary	nutritional status	The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2~3months.	3 months