Periampullary CancerNCT06009224
The Effect of ERAS on Pancreaticoduodenectomy (v2.0)
A study testing ERAS perioperative management in people with Periampullary Cancer and Borderline Malignancy Tumor, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Enhanced Recovery After Surgery (ERAS) is not a program that aims 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 Cancer, Borderline Malignancy Tumor
- What is being tested?
- ERAS perioperative management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2023to 31 Dec 2025
- 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
- Age: 18 to 80 years old
- Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- Resectable or borderline resectable malignant tumor or borderline malignant tumor on the periampullary area
- No distant metastases
- Bone marrow function: White Blood Cell (WBC) at least 3,000/mm3 or Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelet count at least 125,000/mm3
- Liver function: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) less than 3 times the upper limit of normal
- Renal function: Creatinine no greater than 1.5 times the upper limit of normal
- Patients who consented and signed informed consent
Who cannot join
- Patients with distant metastases or patients with recurrent periampullary carcinoma
- Patients with active or uncontrolled infection
- Patients with severe psychiatric/neurological disorders
- People who are addicted to alcohol or other drugs
- Patients included in other clinical studies that may affect this study
- Patients unable to follow the researcher's instructions
Show all 17Show fewer
- Pregnancy
- Patients with uncontrolled heart disease
- Patients with moderate or more comorbidities that are judged to have an impact on quality of life or nutritional status (liver cirrhosis, chronic renal failure, heart failure, etc.)
- Patients who underwent major abdominal organ surgery other than scheduled pancreaticoduodenectomy.
- Patients who require combined resection of other major abdominal organs in addition to scheduled pancreaticoduodenectomy
- History of allergy to local anesthetics
- Local infection at the treatment site
- Patients with neurological or mental health conditions
- A history of spinal surgery or compression fractures at abdominal level
- Patients with coagulopathy (Platelet < 125,000/mm3 or International Normalized Ratio (INR) ≥ 1.5) or who continue to take anticoagulants or antithrombotic drugs without stopping
- Others who are not suitable for research in the judgment of the clinician
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine
Seoul, 05505
About this study
Official title: The Effect of Enhanced Recovery After Surgery (ERAS) on Pancreaticoduodenectomy in Patients With Hepatobiliary-Pancreas (HBP) Disease
Enhanced Recovery After Surgery (ERAS) is not a program that aims 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 are proven in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery.
Investigators performed Randomized Controlled Trials to evaluate the non-inferiority of modified ERAS protocol for pancreaticoduodenectomy (PD) by introducing standardized pre- and post-operative treatment based on ERAS treatment guidelines (ERAS on PD, Research Institute Clinical Progress, 2014-0961; ClinicalTrials.gov, NCT02372331). As a result of the study, the ERAS protocol proved to be non-inferior to the existing pre- and post-operative treatment in terms of surgical complications, mortality, hospital stay, total hospital cost, and most nutritional indicators.
However, the previous study did not include a few important intraoperative items such as epidural analgesia and fluid balance among the main items of the ERAS protocol. This trial aims to evaluate the clinical results by applying the complete ERAS protocol.
Read the detailed description
This study was a single-institution, randomized controlled clinical trial to test the superiority of Enhanced Recovery After Surgery (ERAS) protocol for patients with pancreaticoduodenectomy (PD).
This study will be conducted on adult patients who are planning to undergo pancreaticoduodenectomy for the treatment of periampullary disease for 12 months after the start of the study.
Based on the results of the previous study which choose the functional recovery date as a primary outcome (control group; 9.0 ± 4.3 days, intervention group; 7.6 ± 4.3 days), a total of 334 patients (167 patients in each group) will be enrolled when calculated with power 0.8, α = 0.05, a two-tailed test, and a 10% withdrawal rate.
Investigators plan to randomize patients covered by the existing ERAS program to the control group and patients covered by the full ERAS protocol to the experimental group.
Investigators plan to observe the clinical outcomes up to 3 months after surgery.
The primary outcome is the functional recovery date, and secondary outcomes are the postoperative complication rate, postoperative mortality, and readmission rate.
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 was not defined differently.
- Conditions
- Periampullary Cancer, Borderline Malignancy Tumor
- Being tested
- ERAS perioperative management
- Keywords
- Enhanced Recovery After Surgery, Pancreaticoduodenectomy, Periampullary cancer, Fast track surgery, Postoperative complication
- Medical subject headings
- Postoperative Complications
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
- Epidural analgesia
- Fluid balance
- Other items are the same as conventional
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | Conventional ERAS program |
| Experimental | Experimental | complete ERAS program (Conventional ERAS program + Epidural analgesia + Fluid balance) Receives: Other: ERAS perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery date on postopreative 7th day
- Pain control is possible only with oral or patch-type analgesics without intravenous analgesic administration
- Able to walk freely
- Free eating is possible
- There should be no evidence of infection related to surgery
- No intravenous nutritional injection (total parenteral nutrition) being administered
Measured: The investigators evaluate the five items to the participant starting on the 7th day after surgery. A date that satisfies all five items is defined as functional recovery date.
Secondary outcomes (3)
Postoperative complication
All complications after surgery are included. Especially, delayed gastric emptying, postpancreatectomy hemorrhage, postoperative pancreatic fistula and chyle leak will be classified by the criteria of International Study Group on Pancreatic Surgery.
The severity of all complication will be divided depends on Clavien Dindo classification (Grade from I to V, higher scores mean a better outcome).
Measured: Three months after surgery
Postoperative mortality
All in-hospital mortality and 90 days mortality
Measured: 90 days after surgery
Re-admission rate
For any reason, all readmitted patients are included.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periampullary CancerStudies 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
- 334 participants (estimated)
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., PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009224
- Sponsor's protocol ID
- 2022-1204
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be determined in accordance with the Personal Information Protection Act of KOREA and institutional data sharing regulations.
Publications
Hwang DW, Kim HJ, Lee JH, Song KB, Kim MH, Lee SK, Choi KT, Jun IG, Bang JY, Kim SC. Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2019 Aug;26(8):360-369. doi: 10.1002/jhbp.641. Epub 2019 Jul 2.
PubMed 31152686Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.
PubMed 32161987Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30.
PubMed 26514824Kuemmerli C, Tschuor C, Kasai M, Alseidi AA, Balzano G, Bouwense S, Braga M, Coolsen M, Daniel SK, Dervenis C, Falconi M, Hwang DW, Kagedan DJ, Kim SC, Lavu H, Liang T, Nussbaum D, Partelli S, Passeri MJ, Pecorelli N, Pillai SA, Pillarisetty VG, Pucci MJ, Su W, Sutcliffe RP, Tingstedt B, van der Kolk M, Vrochides D, Wei A, Williamsson C, Yeo CJ, Zani S, Zouros E, Abu Hilal M. Impact of enhanced recovery protocols after pancreatoduodenectomy: meta-analysis. Br J Surg. 2022 Feb 24;109(3):256-266. doi: 10.1093/bjs/znab436.
PubMed 35037019Lee JH, Kim DH, Koh WU. Real-time ultrasound guided thoracic epidural catheterization: a technical review. Anesth Pain Med (Seoul). 2021 Oct;16(4):322-328. doi: 10.17085/apm.21060. Epub 2021 Oct 29.
PubMed 34289297Kim HE, Kim YH, Song KB, Chung YS, Hwang S, Lee YJ, Park KM, Kim SC. Impact of critical pathway implementation on hospital stay and costs in patients undergoing pancreaticoduodenectomy. Korean J Hepatobiliary Pancreat Surg. 2014 Feb;18(1):14-20. doi: 10.14701/kjhbps.2014.18.1.14. Epub 2014 Feb 24.
PubMed 26155241
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enhanced Recovery After Surgery (ERAS) on Pancreaticoduodenectomy in Patients With Hepatobiliary-Pancreas (HBP) Disease
- ClinicalTrials.gov ID
- NCT06009224
- Acronym / sponsor ID
- 2022-1204
- Conditions
- Periampullary Cancer, Borderline Malignancy Tumor
- Keywords
- Enhanced Recovery After Surgery, Pancreaticoduodenectomy, Periampullary cancer, Fast track surgery, Postoperative complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2023 (actual)
- 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 a program that aims 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 are proven in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery.
Investigators performed Randomized Controlled Trials to evaluate the non-inferiority of modified ERAS protocol for pancreaticoduodenectomy (PD) by introducing standardized pre- and post-operative treatment based on ERAS treatment guidelines (ERAS on PD, Research Institute Clinical Progress, 2014-0961; ClinicalTrials.gov, NCT02372331). As a result of the study, the ERAS protocol proved to be non-inferior to the existing pre- and post-operative treatment in terms of surgical complications, mortality, hospital stay, total hospital cost, and most nutritional indicators.
However, the previous study did not include a few important intraoperative items such as epidural analgesia and fluid balance among the main items of the ERAS protocol. This trial aims to evaluate the clinical results by applying the complete ERAS protocol.
Detailed description
This study was a single-institution, randomized controlled clinical trial to test the superiority of Enhanced Recovery After Surgery (ERAS) protocol for patients with pancreaticoduodenectomy (PD).
This study will be conducted on adult patients who are planning to undergo pancreaticoduodenectomy for the treatment of periampullary disease for 12 months after the start of the study.
Based on the results of the previous study which choose the functional recovery date as a primary outcome (control group; 9.0 ± 4.3 days, intervention group; 7.6 ± 4.3 days), a total of 334 patients (167 patients in each group) will be enrolled when calculated with power 0.8, α = 0.05, a two-tailed test, and a 10% withdrawal rate.
Investigators plan to randomize patients covered by the existing ERAS program to the control group and patients covered by the full ERAS protocol to the experimental group.
Investigators plan to observe the clinical outcomes up to 3 months after surgery.
The primary outcome is the functional recovery date, and secondary outcomes are the postoperative complication rate, postoperative mortality, and readmission rate.
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 was 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 | No intervention | –Conventional ERAS program |
| Experimental | Experimental | Other: ERAS perioperative managementcomplete ERAS program (Conventional ERAS program + Epidural analgesia + Fluid balance) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 to 80 years old
- Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- Resectable or borderline resectable malignant tumor or borderline malignant tumor on the periampullary area
- No distant metastases
- Bone marrow function: White Blood Cell (WBC) at least 3,000/mm3 or Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelet count at least 125,000/mm3
Key exclusion criteria (17 listed)
- Patients with distant metastases or patients with recurrent periampullary carcinoma
- Patients with active or uncontrolled infection
- Patients with severe psychiatric/neurological disorders
- People who are addicted to alcohol or other drugs
- Patients included in other clinical studies that may 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* Epidural analgesia * Fluid balance * Other items are the same as conventional | Other | Experimental |
Primary outcome
Functional recovery date on postopreative 7th day
Time frame: The investigators evaluate the five items to the participant starting on the 7th day after surgery. A date that satisfies all five items is defined as functional recovery date.
* Pain control is possible only with oral or patch-type analgesics without intravenous analgesic administration * Able to walk freely * Free eating is possible * There should be no evidence of infection related to surgery * No intravenous nutritional injection (total parenteral nutrition) being administered
3 secondary outcomes
Postoperative complication
Time frame: Three months after surgery
Postoperative mortality
Time frame: 90 days after surgery
Re-admission rate
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Results publication: PubMed 31152686Hwang DW, Kim HJ, Lee JH, Song KB, Kim MH, Lee SK, Choi KT, Jun IG, Bang JY, Kim SC. Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2019 Aug;26(8):360-369. doi: 10.1002/jhbp.641. Epub 2019 Jul 2.
- Results publication: PubMed 32161987Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.
- Results publication: PubMed 26514824Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30.
- Results publication: PubMed 35037019Kuemmerli C, Tschuor C, Kasai M, Alseidi AA, Balzano G, Bouwense S, Braga M, Coolsen M, Daniel SK, Dervenis C, Falconi M, Hwang DW, Kagedan DJ, Kim SC, Lavu H, Liang T, Nussbaum D, Partelli S, Passeri MJ, Pecorelli N, Pillai SA, Pillarisetty VG, Pucci MJ, Su W, Sutcliffe RP, Tingstedt B, van der Kolk M, Vrochides D, Wei A, Williamsson C, Yeo CJ, Zani S, Zouros E, Abu Hilal M. Impact of enhanced recovery protocols after pancreatoduodenectomy: meta-analysis. Br J Surg. 2022 Feb 24;109(3):256-266. doi: 10.1093/bjs/znab436.
- Results publication: PubMed 34289297Lee JH, Kim DH, Koh WU. Real-time ultrasound guided thoracic epidural catheterization: a technical review. Anesth Pain Med (Seoul). 2021 Oct;16(4):322-328. doi: 10.17085/apm.21060. Epub 2021 Oct 29.
- Results publication: PubMed 26155241Kim HE, Kim YH, Song KB, Chung YS, Hwang S, Lee YJ, Park KM, Kim SC. Impact of critical pathway implementation on hospital stay and costs in patients undergoing pancreaticoduodenectomy. Korean J Hepatobiliary Pancreat Surg. 2014 Feb;18(1):14-20. doi: 10.14701/kjhbps.2014.18.1.14. Epub 2014 Feb 24.
- Individual participant dataSharing planned: Undecided. It can be determined in accordance with the Personal Information Protection Act of KOREA and institutional data sharing regulations.
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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., PhD 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 Cancer and Borderline Malignancy 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 17 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Wook Hwang, M.D., PhD (82230103939, drdwhwang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery date on postopreative 7th day (time frame: The investigators evaluate the five items to the participant starting on the 7th day after surgery. A date that satisfies all five items is defined as functional recovery date.). 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 NCT06009224, which also lists 6 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 24 Aug 2023.