Clinical trial · Interventional
The Effect of ERAS on Pancreaticoduodenectomy
The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy
NCT02372331CI-TRIAL-00028056ERAScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Periampullary Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS perioperative management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional perioperative management
- description
- * 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
- type
- EXPERIMENTAL
- label
- ERAS perioperative management
- description
- * behavioral intervention (counselling, audit) * dietary supplement * procedure (preoperative and postoperative) * drug
- interventionNames
- Other: ERAS perioperative management
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDAmerican 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
- BACKGROUNDBalzano 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
- BACKGROUNDBerberat 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
- BACKGROUNDdi 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
- BACKGROUNDFearon 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
- BACKGROUNDKennedy 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.