Enhanced Recovery After SurgeryNCT06256133
Impact of Anesthesia-related Enhanced Recovery After Surgery Components on Mortality After Pancreaticoduodenectomy
An observational study of Enhanced Recovery After Surgery and Mortality, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Pancreaticoduodenectomy (PD), one of the most complex and invasive abdominal surgeries, is associated with long length of stay (LOS) and high morbidity and mortality rates. Enhanced Recovery After Surgery (ERAS) is gaining popularity because it reduces surgical stress and promotes physiological stability through… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enhanced Recovery After Surgery, Mortality
- What is being tested?
- Enhanced Recovery After Surgery protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 355 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2015to 1 Feb 2022
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Department of Hepatobiliary and Pancreatic Surgery initiated the ERAS program without collaborating with the anesthesiology department. Data for 247 patients receiving conventional and Surg-ERAS were extracted from the previous trial from March 2015 to May 2017. Since then, emphasis on the multidisciplinary aspect of the ERAS program has increased, leading to the involvement of the Department of Anesthesiology. From the start of the ERAS collaboration in July 2018, clinical data, including protocol adherence and clinical outcomes, have been prospectively recorded. Subsequently, 355 patients were included and followed up for at least 2 years to assess the relationship between different ERAS bundles and mortality.
- The inclusion cirteria: The participants for this study comprised patients who were enrolled in the previous trial and those who met the same recruitment criteria, except for the inclusion of the ERAS protocol. *the previous trial: 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. Journal of Hepato-Biliary-Pancreatic Sciences 2019; 26:360-9
- The exclusion criteria were as follows: distant metastasis, recurred periampullary cancer, active or uncontrolled infectious disease, severe psychological or neurological disease, alcohol or drug addiction, overlapping with other clinical trials, pregnancy, uncontrolled cardiopulmonary disease, comorbidities that could affect the quality of life and nutritional status (e.g., liver cirrhosis and renal failure), a history of major abdominal surgery (e.g., gastric resection or colonic resection), the need for simultaneous adjacent organ resection (e.g., portal vein, superior mesenteric vein, transverse colon, and liver), and plan to perform minimally invasive PD.
Trial locations and contacts
1 site in 1 country.
About this study
Pancreaticoduodenectomy (PD), one of the most complex and invasive abdominal surgeries, is associated with long length of stay (LOS) and high morbidity and mortality rates. Enhanced Recovery After Surgery (ERAS) is gaining popularity because it reduces surgical stress and promotes physiological stability through standardized perioperative care, thereby improving the recovery process and outcomes after surgery.
ERAS is a comprehensive approach to perioperative care that involves the collaboration of multiple departments. Within the ERAS program, components primarily implemented by the anesthesiology department include preoperative carbohydrate loading, maintenance of near-zero fluid balance, and multimodal analgesic management, such as midthoracic epidural block. However, they may be underutilized for several reasons, such as deviation from conventional methods (e.g., preoperative carbohydrate loading) or the highly demanding nature of the procedures, which require significant human resources, specialized equipment, and time (e.g., thoracic epidural or transverse abdominis block).
Read more
Several randomized trials involving patients undergoing PD have reported that the implementation of ERAS has provided high-level evidence on a safer and quicker recovery, with decreased morbidity rates and shorter LOS than traditional care. Furthermore, a recent study on colorectal surgery reported that the ERAS program may improve not only short-term but also long-term oncological outcomes. However, there is a paucity of research investigating the effects of ERAS on mortality after PD. Furthermore, the impact of anesthesiology-related components within the ERAS pathway has not been extensively studied.
A previously published randomized controlled trial from our institution showed that the outcomes after applying pre- and postoperative ERAS protocols without anesthesiology-related components (Surg-ERAS) were comparable to those of the conventional protocol. This study aimed to compare the short- and long-term mortality rates among patients undergoing PD by examining the same cohort from a previous study, including the conventional (Non-ERAS) and Surg-ERAS groups, in addition to anesthesia fully implementing ERAS programs (ANS-Surg-ERAS group). Moreover, LOS; inflammation parameters, such as neutrophil to lymphocyte ratio (NLR) and C-reactive protein to albumin ratio (CAR); morbidity rate, reoperation rate, and readmission rate were compared among the three groups.
- Conditions
- Enhanced Recovery After Surgery, Mortality
- Being tested
- Enhanced Recovery After Surgery protocol
- Keywords
- Pancreaticoduodenectomy, Enhanced Recovery After Surgery, Mortality, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery protocolProcedure or surgery
Preoperative oral carbohydrate loading, Ultrasound-assisted thoracic epidural catheter placement, Intraoperative individualized goal-directed fluid therapy, Active warming techniques, The inspired fractional concentration of oxygen was maintained, Multimodal postoperative nausea and vomiting (PONV) prevention strategies, Anesthesia was maintained using a target-controlled infusion (TCI) of propofol and remifentanil, Scheduled administration of an intravenous (IV) or oral nonsteroidal anti-inflammatory drug (NSAID) (50 mg of dexketoprofen)
| Study group | Role | What they receive |
|---|---|---|
| ANS-Surg-ERAS group | fully implementing ERAS pathway including anesthesiology-related components Receives: Procedure: Enhanced Recovery After Surgery protocol | |
| Surg-ERAS group | preoperative and postoperative ERAS protocol without anesthesiology-related components | |
| Conventional group | non-ERAS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short- and long-term mortality
The short- (180 days) and long-term (2 years) mortality rates among the three groups
Measured: 180days and 2years (March 2015 to February 2022)
Secondary outcomes (7)
ERAS protocol adherence
Adherance rate of included ERAS protocol components
Measured: Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022)
Length of stay
the number of days from the date of surgery to the date of discharge
Measured: Postoperative, through study completion (March 2015 to February 2022)
Morbidity rate
Postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), and postpancreatic hemorrhage (PPH), pulmonary complication, acute kidney injury
Measured: Within 3 months after surgery (March 2015 to February 2022)
Re-operation rate
Re-operation rate
Measured: Within 30days after surgery (March 2015 to February 2022)
Re-admission rate
Re-admission rate
Measured: Within 30days after surgery (March 2015 to February 2022)
Inflammatory parameters
neutrophil-lymphocyte ratio (NLR) and the C-reactive protein (CRP) to albumin ratio (CAR)
Measured: On the day before surgery and postoperative day 7 ((March 2015 to February 2022)
Weight change
comparing the largest difference between baseline body weight before surgery and weight on postoperative days 30 and 60.
Measured: Pre- and Postoperative(postoperative days 30 and 60) (March 2015 to February 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2015
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyemee Kwon, Asan Medical Center
- Investigators
- Hyemee Kwon, M.D, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256133
- Sponsor's protocol ID
- 2022-0019
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthesia-related Enhanced Recovery After Surgery Components on Mortality After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT06256133
- Acronym / sponsor ID
- 2022-0019
- Conditions
- Enhanced Recovery After Surgery, Mortality
- Keywords
- Pancreaticoduodenectomy, Enhanced Recovery After Surgery, Mortality, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 13 Feb 2024 (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.
Pancreaticoduodenectomy (PD), one of the most complex and invasive abdominal surgeries, is associated with long length of stay (LOS) and high morbidity and mortality rates. Enhanced Recovery After Surgery (ERAS) is gaining popularity because it reduces surgical stress and promotes physiological stability through standardized perioperative care, thereby improving the recovery process and outcomes after surgery.
ERAS is a comprehensive approach to perioperative care that involves the collaboration of multiple departments. Within the ERAS program, components primarily implemented by the anesthesiology department include preoperative carbohydrate loading, maintenance of near-zero fluid balance, and multimodal analgesic management, such as midthoracic epidural block. However, they may be underutilized for several reasons, such as deviation from conventional methods (e.g., preoperative carbohydrate loading) or the highly demanding nature of the procedures, which require significant human resources, specialized equipment, and time (e.g., thoracic epidural or transverse abdominis block).
Several randomized trials involving patients undergoing PD have reported that the implementation of ERAS has provided high-level evidence on a safer and quicker recovery, with decreased morbidity rates and shorter LOS than traditional care. Furthermore, a recent study on colorectal surgery reported that the ERAS program may improve not only short-term but also long-term oncological outcomes. However, there is a paucity of research investigating the effects of ERAS on mortality after PD. Furthermore, the impact of anesthesiology-related components within the ERAS pathway has not been extensively studied.
A previously published randomized controlled trial from our institution showed that the outcomes after applying pre- and postoperative ERAS protocols without anesthesiology-related components (Surg-ERAS) were comparable to those of the conventional protocol. This study aimed to compare the short- and long-term mortality rates among patients undergoing PD by examining the same cohort from a previous study, including the conventional (Non-ERAS) and Surg-ERAS groups, in addition to anesthesia fully implementing ERAS programs (ANS-Surg-ERAS group). Moreover, LOS; inflammation parameters, such as neutrophil to lymphocyte ratio (NLR) and C-reactive protein to albumin ratio (CAR); morbidity rate, reoperation rate, and readmission rate were compared among the three groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANS-Surg-ERAS group | – | Procedure: Enhanced Recovery After Surgery protocolfully implementing ERAS pathway including anesthesiology-related components |
| Surg-ERAS group | – | –preoperative and postoperative ERAS protocol without anesthesiology-related components |
| Conventional group | – | –non-ERAS group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Department of Hepatobiliary and Pancreatic Surgery initiated the ERAS program without collaborating with the anesthesiology department. Data for 247 patients receiving conventional and Surg-ERAS were extracted from the previous trial from March 2015 to May 2017. Since then, emphasis on the multidisciplinary aspect of the ERAS program has increased, leading to the involvement of the Department of Anesthesiology. From the start of the ERAS collaboration in July 2018, clinical data, including protocol adherence and clinical outcomes, have been prospectively recorded. Subsequently, 355 patients were included and followed up for at least 2 years to assess the relationship between different ERAS bundles and mortality.
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 |
|---|---|---|
| Enhanced Recovery After Surgery protocolPreoperative oral carbohydrate loading, Ultrasound-assisted thoracic epidural catheter placement, Intraoperative individualized goal-directed fluid therapy, Active warming techniques, The inspired fractional concentration of oxygen was maintained, Multimodal postoperative nausea and vomiting (PONV) prevention strategies, Anesthesia was maintained using a target-controlled infusion (TCI) of propofol and remifentanil, Scheduled administration of an intravenous (IV) or oral nonsteroidal anti-inflammatory drug (NSAID) (50 mg of dexketoprofen) | Procedure or surgery | ANS-Surg-ERAS group |
Primary outcome
Short- and long-term mortality
Time frame: 180days and 2years (March 2015 to February 2022)
The short- (180 days) and long-term (2 years) mortality rates among the three groups
7 secondary outcomes
ERAS protocol adherence
Time frame: Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022)
Length of stay
Time frame: Postoperative, through study completion (March 2015 to February 2022)
Morbidity rate
Time frame: Within 3 months after surgery (March 2015 to February 2022)
Re-operation rate
Time frame: Within 30days after surgery (March 2015 to February 2022)
Re-admission rate
Time frame: Within 30days after surgery (March 2015 to February 2022)
Inflammatory parameters
Time frame: On the day before surgery and postoperative day 7 ((March 2015 to February 2022)
Weight change
Time frame: Pre- and Postoperative(postoperative days 30 and 60) (March 2015 to February 2022)
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 13 Feb 2024.
- Individual participant dataSharing planned: Undecided. The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.
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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.
Hyemee Kwon, M.D, Ph.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?
An observational study of Enhanced Recovery After Surgery and Mortality, 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?
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 13 Feb 2024. 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?
Short- and long-term mortality (time frame: 180days and 2years (March 2015 to February 2022)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.