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

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Diagnosis and Treatment of Complications After Esophagectomy

Treatments: Other: Wash-in period; Diagnostic Test: Algorithm-based care

Study type: Interventional

Funder types: Other

Identifiers

NCT06762652

10390032310024 (Other Grant/Funding Number)

2024-17562

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,050 participants in 1 patient group

Usual Care

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Algorithm-based care

Other: Wash-in period