Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC)

Recruiting

• Conditions: Quality of Life; Dysphagia
• Interventions: Other: EORTC QLQ-C30; Other: EORTC QLQ-OG25; Other: GIQLI; Other: SWAL QoL; Procedure: Videofluoroscopy

• Registration Number: NCT05802459
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Study Timeline

• Study Start: 2022-12-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2025-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing complex esophageal reconstruction	EORTC QLQ-C30	All the 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.
Patients undergoing complex esophageal reconstruction	EORTC QLQ-OG25	All the 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.
Patients undergoing complex esophageal reconstruction	Videofluoroscopy	All the 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.
Patients undergoing complex esophageal reconstruction	GIQLI	All the 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.
Patients undergoing complex esophageal reconstruction	SWAL QoL	All the 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.

Primary Outcome Measures

Name	Time	Method
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.	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.	This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire.	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.	This study aims to determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged) using the following questionnaires: * European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30): All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.; * European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25): All of the scales and single-item measures range in score from 0 to 100. A high score for all the scales and single-items represents a high level of symptomatology or problems.; * Gastrointestinal quality of life index (GIQLI): scale range from 0-144; * Swallowing quality of life questionnaire (SWAL QoL): scale range from 0-100

Secondary Outcome Measures

Name	Time	Method
Number (percentage) of dilatations of the conduit	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.	Number (percentage) of dilatations of the conduit, per patient, carried out during the UDE within the follow-up visits: one year, two and three years.
Number (percentage) of patients with chronic diarrhea	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.	Number (percentage) of patients with chronic diarrhea during follow-up
Serum albumin value	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 of albumin/prealbumin in blood tests for assessment of nutritional status. Normal value: 34 - 54 g/L
Volume of enteral nutrition required	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.	Volume of enteral nutrition required during the post-surgical follow-up period.
Incidence of stenosis of the conduit	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.	Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE) that requires some therapeutic maneuver (dilatation), which is carried out during the follow-up visits: one year, two and three years.
Number (percentage) of patients with esophagitis	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.	Number (percentage) of patients with esophagitis according to the Los Angeles classification evidenced in any of the UDE performed during the follow-up visits: one year, two and three years.
Body Mass Index	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.	Weight and height will be combined to report Body Mass Index (BMI kg/m2) as a measure for indicating nutritional status
Number of hospitalizations	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.	Number of hospitalizations, for any reason, during the post-surgical follow-up period.
Incidence of dysphagia	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.	Incidence of dysphagia evaluated by Videofluoroscopic (VDF) using the following scales: * Videofluoroscopic dysphagia scale (VDS); * Dysphagia outcome and severity scale(DOSS); * Penetration-aspiration scale(PAS)
Mean 'time of need for enteral nutrition and oral nutrition supplements'	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.	Mean 'time of need for enteral nutrition and oral nutrition supplements' during the post-surgical follow-up period.
Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG)	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.	Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG) (20), highlighting anastomotic dehiscence, surgical site infection, bleeding, need for reintervention, ischaemia of the graft (up to 90 ±3 days after surgery). Number (percentage) of complications according to the Clavien-Dindo classification (21) and Comprehensive Complication Index.
Muscle strength measured by Handgrip strength (HGS) dynamometer	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.	Handgrip strength expressed in Kg and assessed using the reference values for age and sex
Mortality	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.	Number (percentage) of deaths related to esophageal reconstruction (Up to 90 ±3 days after surgery).

Trial Locations

Locations (1)

Hospital Uversitari de Bellvitge; 🇪🇸 Barcelona, Spain