The Effect of ERAS on Pancreaticoduodenectomy

NCT02372331 | Completed

• 1 other identifier: ERAS
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periampullary Tumor

Keywords

pancreaticoduodenectomy; ERAS; Whipple's operation; Fast track

Outcome Measures

Primary Outcomes (1)

• Morbidity

  The incidence of operation-related morbidity

  3 months

Secondary Outcomes (3)

• Mortality

  3 months

• length of stay

  3 months

• nutritional status

  3 months

Study Arms (2)

Conventional perioperative management

NO INTERVENTION

* Preop usual biliary drainage * Preop smoking and alcohol * Preop parenteral nutrition * Oral bowel preparation (mechanical bowel preparation ) * Preoperative fasting \> 12 hours * Pre-anesthetic medication * Anti-thrombotic prophylaxis * Antimicrobial prophylaxis and skin preparation * Intravenous analgesia : PCA * Prevention of postoperative nausea and vomiting (PONV) (X) * Incision : surgeon direction * Avoiding hypothermia * Nasogastric intubation (O) * Postop glycemic control * Positive fluid balance * Perianastomotic drain removal over POD #5 * Somatostatin analogues * Transurethral catheter removal * Delayed gastric emptying(DGE) (+) , parenteral nutrition (+) * Postop routine artificial nutrition (O), soft diet at POD #5 * Early and scheduled mobilization

ERAS perioperative management

EXPERIMENTAL

* behavioral intervention (counselling, audit) * dietary supplement * procedure (preoperative and postoperative) * drug

Other: ERAS perioperative management

Interventions

ERAS perioperative management OTHER

* 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

Also known as: Fast tract

ERAS perioperative management

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138736, South Korea

Location

Related 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. No abstract available.

  PMID: 21307770 BACKGROUND

• 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.

  PMID: 18844251 BACKGROUND

• Berberat PO, Ingold H, Gulbinas A, Kleeff J, Muller MW, Gutt C, Weigand M, Friess H, Buchler MW. Fast track--different implications in pancreatic surgery. J Gastrointest Surg. 2007 Jul;11(7):880-7. doi: 10.1007/s11605-007-0167-2.

  PMID: 17440787 BACKGROUND

• 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.

  PMID: 20703500 BACKGROUND

• 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. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

  PMID: 15896435 BACKGROUND

• 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. doi: 10.1016/j.jamcollsurg.2007.01.057.

  PMID: 17481510 BACKGROUND

• 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: 22956014 BACKGROUND

• 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.

  PMID: 19841366 BACKGROUND

• 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. doi: 10.1160/me0406.

  PMID: 17694232 BACKGROUND

• 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.

  PMID: 20116145 BACKGROUND

Study Officials

• Dae Wook Hwang, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 26, 2015
• Study Start: March 4, 2015
• Primary Completion: May 10, 2017
• Study Completion: May 26, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)