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The goal of this prospective population-based cohort study is to assess:
Participants
-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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing complex esophageal reconstruction | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EORTC QLQ-C30 | Other | central generic questionnaire associated with different disease specific modules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire. | 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:
| 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 who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit. | This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged). | 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 | Description | Time Frame |
|---|---|---|
| Incidence of dysphagia | Incidence of dysphagia evaluated by Videofluoroscopic (VDF) using the following scales:
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Miró | Contact | +34932607500 | mmiro@bellvitgehospital.cat | |
| Rodrigo Hermoza | Contact | +34932607500 | rhermoza@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Leandre Farran | Hospital Universitari de Bellvitge | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Uversitari de Bellvitge | Recruiting | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17512272 | Background | Bothereau H, Munoz-Bongrand N, Lambert B, Montemagno S, Cattan P, Sarfati E. Esophageal reconstruction after caustic injury: is there still a place for right coloplasty? Am J Surg. 2007 Jun;193(6):660-4. doi: 10.1016/j.amjsurg.2006.08.074. | |
| 18448026 | Background | Farran-Teixido L, Miro-Martin M, Biondo S, Conde-Mourino R, Bettonica-Larranaga C, Aranda Danso H, Sans-Segarra M, Rafecas-Renau A. [Second time esophageal reconstruction surgery: coloplasty and gastroplasty]. Cir Esp. 2008 May;83(5):242-6. doi: 10.1016/s0009-739x(08)70561-x. Spanish. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| EORTC QLQ-OG25 | Other | module to assess the quality of life in patients with esophagogastric disease. |
|
| GIQLI | Other | Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale. |
|
| SWAL QoL | Other | Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia. |
|
| Videofluoroscopy | Procedure | It consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia. |
|
| Incidence of stenosis of the conduit | 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. | 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 | 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. | 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 | 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. | 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 | Number (percentage) of patients with chronic diarrhea during follow-up | 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. |
| Body Mass Index | Weight and height will be combined to report Body Mass Index (BMI kg/m2) as a measure for indicating nutritional status | 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. |
| Muscle strength measured by Handgrip strength (HGS) dynamometer | Handgrip strength expressed in Kg and assessed using the reference values for age and sex | 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. |
| Serum albumin value | Measure of albumin/prealbumin in blood tests for assessment of nutritional status. Normal value: 34 - 54 g/L | 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' | Mean 'time of need for enteral nutrition and oral nutrition supplements' during the post-surgical follow-up period. | 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 | Volume of enteral nutrition required during the post-surgical follow-up period. | 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 | Number of hospitalizations, for any reason, during the post-surgical follow-up period. | 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) | 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. | 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. |
| Mortality | Number (percentage) of deaths related to esophageal reconstruction (Up to 90 ±3 days after surgery). | 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. |
| 28881882 | Background | Irino T, Tsekrekos A, Coppola A, Scandavini CM, Shetye A, Lundell L, Rouvelas I. Long-term functional outcomes after replacement of the esophagus with gastric, colonic, or jejunal conduits: a systematic literature review. Dis Esophagus. 2017 Dec 1;30(12):1-11. doi: 10.1093/dote/dox083. |
| 24129668 | Background | Jacobs M, Macefield RC, Elbers RG, Sitnikova K, Korfage IJ, Smets EM, Henselmans I, van Berge Henegouwen MI, de Haes JC, Blazeby JM, Sprangers MA. Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery. Qual Life Res. 2014 May;23(4):1097-115. doi: 10.1007/s11136-013-0545-z. Epub 2013 Oct 16. |
| 29459004 | Background | Miro M, Farran L, Estremiana F, Miquel J, Escalante E, Aranda H, Bettonica C, Galan M. Does gastric conditioning decrease the incidence of cervical oesophagogastric anastomotic leakage? Cir Esp (Engl Ed). 2018 Feb;96(2):102-108. doi: 10.1016/j.ciresp.2017.11.012. Epub 2018 Feb 17. English, Spanish. |
| 18477261 | Background | Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x. |
| 21277572 | Background | Farran Teixidor L, Vinals Vinals JM, Miro Martin M, Higueras Sune C, Bettonica Larranaga C, Aranda Danso H, Lopez Ojeda A, Rafecas Renau A. [Supercharged ileocoloplasty: an option for complex oesophageal reconstructions]. Cir Esp. 2011 Feb;89(2):87-93. doi: 10.1016/j.ciresp.2010.10.009. Epub 2011 Feb 1. Spanish. |
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| 32677925 | Background | Jiang S, Guo C, Zou B, Xie J, Xiong Z, Kuang Y, Tang J. Comparison of outcomes of pedicled jejunal and colonic conduit for esophageal reconstruction. BMC Surg. 2020 Jul 16;20(1):156. doi: 10.1186/s12893-020-00810-y. |
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| D010038 | Otorhinolaryngologic Diseases |