Diagnosis and Treatment of Complications After EsophagectomyRESCUENCT06762652
ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial
A study testing Wash-in period and Algorithm-based care in people with Diagnosis and Treatment of Complications After Esophagectomy, run by Radboud University Medical Center.
Trial summary
The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis and Treatment of Complications After Esophagectomy
- What is being tested?
- Wash-in period and Algorithm-based care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 18 years
- Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
- Scheduled to undergo curatively-intended esophagectomy with gastric tube reconstruction. All techniques (i.e. minimally invasive, robotic, hybrid, open) and approaches (i.e. transthoracic, transcervical, transhiatal) of esophagectomy are suitable for inclusion.
- Ability to provide written informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Emergency resection
- Patients who underwent (additional) total gastrectomy
- Patients who underwent reconstruction using colonic or jejunal interposition
- Patients in whom no anastomosis is created during resection
- Secondary malignancy which determines prognosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gijs van Dongen, MD contact
About this study
The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer.
- Being tested
- Wash-in period, Algorithm-based care
- Keywords
- diagnosis, treatment, complications, esophagectomy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wash-in periodOther
The goal of the wash-in period between the control and intervention period is to intensively educate and train physicians to use the algorithm as intended during daily postoperative care. The coordinating investigator along with the local principal investigator will be responsible for this training. Training will be performed in a standardized approach in order to guarantee uniformity across centres.
Algorithm-based careDiagnostic test
During the intervention period, (participating) patients will receive algorithm-based care. The RESCUE algorithm is a consensus-based clinical care algorithm developed to standardize postoperative care. The algorithm includes the same modalities as applied in usual care, and does not include novel/experimental modalities, but rather offers a novel, standardized approach to guide the use of common modalities during postoperative care. The daily objective evaluation of patients' condition, vital signs and biochemical parameters is thought to aid early diagnosis of complications after esophagectomy which enables treatment before systemic symptoms become apparent and prevent development of sepsis. Physicians are always allowed to deviate from the RESCUE, but reasons for deviating will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | During the control period, (participating) patients will receive usual postoperative care. Postoperative care, including diagnosis and management of postoperative complications, will be performed in line with local standards and/or protocols. For diagnosis of complications, physicians may perform laboratory tests such as CRP or leucocyte count, and diagnostic imaging such as CT-scan, X-ray or endoscopy. For treatment of complications, conservative, radiological, endoscopic and surgical treatments are often applied. Receives: Other: Wash-in period; Diagnostic Test: Algorithm-based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complications
The primary outcome measure is the incidence of severe complications (i.e. Clavien-Dindo ≥ 3b). Severe complications are defined as a composite endpoint with one or more of the following criteria within 90 days after esophagectomy:
- The complication was treated under general anaesthesia.
- Postoperative mortality.
- Escalation of care due to new onset or progressive organ failure (i.e. patients requiring vasopression, dialysis, (re-)intubation, (re)admission to a medium care or intensive care unit).
Measured: 90 days
Secondary outcomes (11)
General quality of life
General quality of life, as measured using the validated EuroQol EQ-5D-5L questionnaire. Assessment will be performed at 6 weeks and 3, 6 and 12 months.
Measured: 6 weeks, and 3, 6, and 12 months after esophagectomy
Time to functional recovery
Time to functional recovery, defined as when a patient does not need intravenous fluid, has adequate pain control with oral analgesia (Numeric Rating Scale ≤4), restored mobility to an independent level (e.g. walk to the toilet with(out) walking aids and transfer bed/chair) or back to the previous functioning level of mobilization, sufficient caloric intake (minimum of 50% of the required calories), no signs of an active infection (no fever and declining CRP levels).
Measured: 90 days after esophagectomy
Comprehensive Complications index
Comprehensive Complications Index, a measure for the severity of all complications together.
Measured: 90 days after esophagectomy
Failure to rescue
Failure to rescue, defined as the rate of mortality in patients with a complication within 90-days after esophagectomy.
Measured: 90 days after esophagectomy
Length of hospital (intensive care unit) stay
Length of hospital and ICU stay, defined as the amount of days the patient stays in the ICU and in the hospital during 90 days postoperatively.
Measured: 90 days after esophagectomy
Succes of algorithm implementation
succes of implementation (i.e. proportion of patients' days in which the algorithm was not followed)
Measured: 90 days after esophagectomy
Economic evaluation
Cost-efficacy analysis will be performed from a societal perspective, including both medical and non-medical costs. Economic evaluation will be performed at 12 months follow-up. Medical resource use will be recorded from hospital records, including length of stay, laboratory and diagnostics use and treatment of complications. Medical resource use as well as out-of-pocket expenses will be recorded using iMTA Medical Consumption Questionnaire (iMCQ). [26] Resource use will be multiplied by associated unit costs to obtain total costs. Standard cost prices from the 'Dutch Guidelines for Cost Analyses' and www.medicijnkosten.nl will be used. Volumes of care will be multiplied by the cost price of each volume to calculate costs.
Measured: 3,6 and 12 months after esophagectomy
Productivity losses
Productivity losses will be measured using the iMTA Productivity Cost Questionnaire (iPCQ).
Measured: 3,6 and 12 months after esophagectomy
Budget Impact Analysis
Budget Impact Analysis (BIA) will be performed to assess the financial consequences of implementing the algorithm-based care, wherein the internationally accepted principles of ISPOR for the design, implementation and reporting of the BIA will be used. The third party payer perspective will be adopted to inform a business case for reimbursement companies.
Measured: 3,6 and 12 months after esophagectomy
Cancer-specific quality of life
Cancer-specific quality of life, as measured using the validated EIRTC QLQ-C30 questionnaire. Assessment will be performed at 6 weeks and 3, 6 and 12 months.
Measured: 6 weeks, and 3, 6, and 12 months after esophagectomy
Esophageal cancer-specific quality of life
Esophageal cancer-specific quality of life, as measured using the validated EORTC QLQ-OG25 questionnaire. Assessment will be performed at 6 weeks and 3, 6 and 12 months.
Measured: 6 weeks, and 3, 6, and 12 months after esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis and Treatment of Complications After EsophagectomyStudies of the same condition, open and under way.
- More trials run by Radboud University 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
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster-randomized superiority trial.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, University Medical Center Groningen, Hospital Group Twente (ZGT), Antoni van Leeuwenhoek Hospital, Leiden University Medical Center, Elisabeth-TweeSteden Ziekenhuis, medical center leeuwarden, Zuyderland Medical Centre, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Reinier de Graaf Groep, Gelre Hospitals, UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762652
- Sponsor's protocol ID
- 2024-17562
- Other IDs
- 10390032310024
- Acronym
- RESCUE
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This concerns a conceptual registration.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial
- ClinicalTrials.gov ID
- NCT06762652
- Acronym / sponsor ID
- RESCUE / 2024-17562
- Keywords
- diagnosis, treatment, complications, esophagectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, University Medical Center Groningen, Hospital Group Twente (ZGT), Antoni van Leeuwenhoek Hospital, Leiden University Medical Center, Elisabeth-TweeSteden Ziekenhuis, medical center leeuwarden, Zuyderland Medical Centre, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Reinier de Graaf Groep, Gelre Hospitals, UMC Utrecht
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Jan 2025 (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.
The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped-wedge cluster-randomized superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Wash-in period, Diagnostic Test: Algorithm-based careDuring the control period, (participating) patients will receive usual postoperative care. Postoperative care, including diagnosis and management of postoperative complications, will be performed in line with local standards and/or protocols. For diagnosis of complications, physicians may perform laboratory tests such as CRP or leucocyte count, and diagnostic imaging such as CT-scan, X-ray or endoscopy. For treatment of complications, conservative, radiological, endoscopic and surgical treatments are often applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 18 years
- Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
- Scheduled to undergo curatively-intended esophagectomy with gastric tube reconstruction. All techniques (i.e. minimally invasive, robotic, hybrid, open) and approaches (i.e. transthoracic, transcervical, transhiatal) of esophagectomy are suitable for inclusion.
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Emergency resection
- Patients who underwent (additional) total gastrectomy
- Patients who underwent reconstruction using colonic or jejunal interposition
- Patients in whom no anastomosis is created during resection
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 |
|---|---|---|
| Wash-in periodThe goal of the wash-in period between the control and intervention period is to intensively educate and train physicians to use the algorithm as intended during daily postoperative care. The coordinating investigator along with the local principal investigator will be responsible for this training. Training will be performed in a standardized approach in order to guarantee uniformity across centres. | Other | Usual Care |
| Algorithm-based careDuring the intervention period, (participating) patients will receive algorithm-based care. The RESCUE algorithm is a consensus-based clinical care algorithm developed to standardize postoperative care. The algorithm includes the same modalities as applied in usual care, and does not include novel/experimental modalities, but rather offers a novel, standardized approach to guide the use of common modalities during postoperative care. The daily objective evaluation of patients' condition, vital signs and biochemical parameters is thought to aid early diagnosis of complications after esophagectomy which enables treatment before systemic symptoms become apparent and prevent development of sepsis. Physicians are always allowed to deviate from the RESCUE, but reasons for deviating will be recorded. | Diagnostic test | Usual Care |
Primary outcome
Severe complications
Time frame: 90 days
The primary outcome measure is the incidence of severe complications (i.e. Clavien-Dindo ≥ 3b). Severe complications are defined as a composite endpoint with one or more of the following criteria within 90 days after esophagectomy: 1. The complication was treated under general anaesthesia. 2. Postoperative mortality. 3. Escalation of care due to new onset or progressive organ failure (i.e. patients requiring vasopression, dialysis, (re-)intubation, (re)admission to a medium care or intensive care unit).
11 secondary outcomes
General quality of life
Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy
Time to functional recovery
Time frame: 90 days after esophagectomy
Comprehensive Complications index
Time frame: 90 days after esophagectomy
Failure to rescue
Time frame: 90 days after esophagectomy
Length of hospital (intensive care unit) stay
Time frame: 90 days after esophagectomy
Succes of algorithm implementation
Time frame: 90 days after esophagectomy
Economic evaluation
Time frame: 3,6 and 12 months after esophagectomy
Productivity losses
Time frame: 3,6 and 12 months after esophagectomy
Budget Impact Analysis
Time frame: 3,6 and 12 months after esophagectomy
Cancer-specific quality of life
Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy
Esophageal cancer-specific quality of life
Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided. This concerns a conceptual registration.
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.
Gijs van Dongen, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Wash-in period and Algorithm-based care in people with Diagnosis and Treatment of Complications After Esophagectomy, run by Radboud University Medical Center.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jobbe M.G. Lemmens, MD (0652331762, Jobbe.Lemmens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe complications (time frame: 90 days). 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 7 Jan 2025.