Clinical trial NCT05802459: Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC)
Official title: Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Dysphagia
Keywords: Esophageal reconstruction
Quality of life
Coloplasty
Jejunoplasty
Dysphagia
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period.

All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.

Brief summary: The goal of this prospective population-based cohort study is to assess:

* The evolution of the functional status of patients undergoing complex esophageal reconstruction
* Its impact on quality of life, depending on the type of conduit performed.

Participants

* Will be asked to complete different quality of life questionnaires during every follow-up visit
* Will undergo additional tests to assess functionality

Detailed description: -General Justification: In recent years, esophageal reconstruction has been a great surgical challenge for the multidisciplinary teams in charge of carrying out this complex technique, associated with high morbidity and a high impact on the quality of life and functional status of patients.

One of the most important aspects of this surgery is the type of conduit used to restore digestive transit. Classically, gastroplasty has been the technique of choice due to its lower morbidity and mortality and less surgical complexity. On the other hand, in those patients in whom the stomach is not available, a coloplasty or a jejunoplasty is chosen, both of which can be associated with supercharged techniques to improve and ensure good vascular flow.

Currently, there is controversy about which type of conduit to use in the absence of a viable stomach. Since the introduction of microvascular or supercharged techniques, the postoperative results of jejunal grafts are comparable to coloplasty and even gastroplasty according to some authors.

The present study is an initiative of the Complex Esophageal Reconstruction Unit (UREC) of Bellvitge University Hospital (HUB), which aims to compare the different types of conduit used in complex esophageal reconstruction, assessing, in the short and long term, the postoperative functional status and its impact on quality of life through validated test-type tools, as well as carrying out complementary tests that allow evaluating aspects such as swallowing and dysphagia, among others.

* Hypothesis Considering the results of quality of life and functionality in the short and long term, jejunoplasty (free, pedunculated ± supercharged) could be the second technique of choice to perform in the absence of gastric conduit in complex esophageal reconstruction.
* Primary objective:

  1. To determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
  2. To describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
* Study design CEREC-2022 is a prospective population-based cohort study that aims to assess the evolution of the functional status of patients undergoing complex esophageal reconstruction and its impact on quality of life, depending on the type of conduit performed.
* Study population The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.
* Main Outcome

  1. Quality of life related to the swallowing function based on the conduit: it will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30), European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25), Gastrointestinal quality of life index (GIQLI) and Swallowing quality of life questionnaire (SWAL QoL)
  2. Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
* Secondary outcome Incidence of dysphagia evaluated by Videofluoroscopy (VDF), Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE), Number (percentage) of dilatations of the conduit, Number (percentage) of patients with esophagitis according to the Los Angeles classification, Nutritional status, Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group, Number of hospitalizations.
* As this is an observational study of a low-prevalent surgical indication, it is expected to include all patients scheduled for surgery from September 2022 to September 2025.
* The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years of age) and of both gender.
* Candidates for complete esophageal reconstruction with cervical anastomosis, regardless of the etiology of the esophagectomy.
* Decision to indicate a coloplasty (+/- supercharged) or jejunoplasty (free, pedunculated +/- supercharged) as surgical technique after evaluation by the UREC Committee.
* Acceptance to participate in the study and comply with the program of procedures (schedule of visits).
* Signing of the informed consent.

Exclusion Criteria:

* Patients who withdraw their informed consent at any time during the course of the study.

Primary outcomes:
measure: Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire.
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Secondary outcomes:
measure: Incidence of dysphagia
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Incidence of stenosis of the conduit
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Number (percentage) of dilatations of the conduit
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Number (percentage) of patients with esophagitis
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Number (percentage) of patients with chronic diarrhea
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Body Mass Index
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Muscle strength measured by Handgrip strength (HGS) dynamometer
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Serum albumin value
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Mean 'time of need for enteral nutrition and oral nutrition supplements'
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Volume of enteral nutrition required
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Number of hospitalizations
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG)
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
measure: Mortality
timeFrame: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Uversitari de Bellvitge
Study officials:
affiliation: Bellvitge University Hospital
name: Leandre Farran
role: STUDY_DIRECTOR
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