ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial (RESCUE)

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 Overview

• Status: Not yet recruiting
• Conditions: Diagnosis and Treatment of Complications After Esophagectomy
• Intervention / Treatment: Other: Wash-in period; Diagnostic test: Algorithm-based care

• Study Type: Interventional
• Enrollment (Estimated): 1050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jobbe M.G. Lemmens, MD; Phone Number: 0652331762; Email: Jobbe.Lemmens@radboudumc.nl
• Study Contact Backup: Name: Gijs van Dongen, MD; Email: gijs.vandongen@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Age ≥ 18 years
2. Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
3. 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.
4. Ability to provide written informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Emergency resection
2. Patients who underwent (additional) total gastrectomy
3. Patients who underwent reconstruction using colonic or jejunal interposition
4. Patients in whom no anastomosis is created during resection
5. Secondary malignancy which determines prognosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Usual Care; 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.

Other: Wash-in period; 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.; Diagnostic test: Algorithm-based care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	90 days after esophagectomy
Comprehensive Complications index	Comprehensive Complications Index, a measure for the severity of all complications together.	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.	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.	90 days after esophagectomy
Succes of algorithm implementation	succes of implementation (i.e. proportion of patients' days in which the algorithm was not followed)	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.	3,6 and 12 months after esophagectomy
Productivity losses	Productivity losses will be measured using the iMTA Productivity Cost Questionnaire (iPCQ).	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.	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.	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.	6 weeks, and 3, 6, and 12 months after esophagectomy

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Catharina Ziekenhuis Eindhoven; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University Medical Center; Elisabeth-TweeSteden Ziekenhuis; Reinier de Graaf Groep; Zuyderland Medical Centre; Gelre Hospitals; Hospital Group Twente (ZGT); Antoni van Leeuwenhoek Hospital; medical center leeuwarden

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: treatment; complications; diagnosis; esophagectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2024-17562; 10390032310024 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This concerns a conceptual registration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No