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

NCT ID: NCT06762652

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-07-01

Brief 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.

Conditions

Diagnosis and Treatment of Complications After Esophagectomy

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Wash-in period

Intervention Type: OTHER

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 care

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Hospital Group Twente (ZGT)

UNKNOWN

Sponsor Role: collaborator

Antoni van Leeuwenhoek Hospital

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role: collaborator

medical center leeuwarden

UNKNOWN

Sponsor Role: collaborator

Zuyderland Medical Centre

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Reinier de Graaf Groep

OTHER

Sponsor Role: collaborator

Gelre Hospitals

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jobbe M.G. Lemmens, MD

Role: CONTACT

Jobbe.Lemmens@radboudumc.nl

0652331762

Gijs van Dongen, MD

Role: CONTACT

gijs.vandongen@radboudumc.nl

Other Identifiers

10390032310024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-17562

Identifier Type: -

Identifier Source: org_study_id