Periampullary TumorERASNCT02372331
The Effect of ERAS on Pancreaticoduodenectomy
A study testing ERAS perioperative management in people with Periampullary Tumor, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periampullary Tumor
- What is being tested?
- ERAS perioperative management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2015to 26 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy
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.
Read the detailed 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
- Conditions
- Periampullary Tumor
- Being tested
- ERAS perioperative management
- Keywords
- pancreaticoduodenectomy, ERAS, Whipple's operation, Fast track
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS perioperative managementOther
Also called Fast tract
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ERAS perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
The incidence of operation-related morbidity
Measured: 3 months
Secondary outcomes (3)
Mortality
The incidence of 30 days mortality and in-hospital mortality
Measured: 3 months
length of stay
postoperative length of stay
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study start4 Mar 2015
- Primary completion10 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Periampullary TumorStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Wook Hwang, Asan Medical Center
- Investigators
- Dae Wook Hwang, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372331
- Sponsor's protocol ID
- ERAS
- Acronym
- ERAS
- Status last verified
- Jun 2017
- First submitted
- 12 Feb 2015
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: At initial status of this study, IRB was approved at limited data access only.
Publications
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.
PubMed 21307770Balzano 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.
PubMed 18844251Berberat 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.
PubMed 17440787di 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.
PubMed 20703500Fearon 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.
PubMed 15896435Kennedy 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.
PubMed 17481510Lassen 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.
PubMed 22956014Lassen 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.
PubMed 19841366Stergiopoulou 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.
PubMed 17694232Varadhan 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.
PubMed 20116145
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT02372331
- Acronym / sponsor ID
- ERAS / ERAS
- Conditions
- Periampullary Tumor
- Keywords
- pancreaticoduodenectomy, ERAS, Whipple's operation, Fast track
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 4 Mar 2015 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: ERAS perioperative management* behavioral intervention (counselling, audit) * dietary supplement * procedure (preoperative and postoperative) * drug |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS perioperative managementAlso: Fast tract* 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 | Other | ERAS perioperative management |
Primary outcome
Morbidity
Time frame: 3 months
The incidence of operation-related morbidity
3 secondary outcomes
Mortality
Time frame: 3 months
length of stay
Time frame: 3 months
nutritional status
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Background: PubMed 21307770American 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.
- Background: PubMed 18844251Balzano 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.
- Background: PubMed 17440787Berberat 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.
- Background: PubMed 20703500di 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.
- Background: PubMed 15896435Fearon 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.
- Background: PubMed 17481510Kennedy 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.
- Background: PubMed 22956014Lassen 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.
- Background: PubMed 19841366Lassen 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.
- Background: PubMed 17694232Stergiopoulou 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.
- Background: PubMed 20116145Varadhan 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.
- Individual participant dataSharing planned: No. At initial status of this study, IRB was approved at limited data access only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Wook Hwang, M.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS perioperative management in people with Periampullary Tumor, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02372331, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.