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

Quality of Life Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802459
• Other study ID #: CEREC-2022
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: September 2027

Study information

• Verified date: March 2023
• Source: Hospital Universitari de Bellvitge
• Contact: Monica Miró
• Phone: +34932607500
• Email: mmiro[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Quality of Life

Intervention

Other:
• EORTC QLQ-C30
central generic questionnaire associated with different disease specific modules
• EORTC QLQ-OG25
module to assess the quality of life in patients with esophagogastric disease.
• GIQLI
Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale.
• SWAL QoL
Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia.

Procedure:
• Videofluoroscopy
It consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia.

Locations

Country	Name	City	State
Spain	Hospital Uversitari de Bellvitge	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (26)

Blackmon SH, Correa AM, Skoracki R, Chevray PM, Kim MP, Mehran RJ, Rice DC, Roth JA, Swisher SG, Vaporciyan AA, Yu P, Walsh GL, Hofstetter WL. Supercharged pedicled jejunal interposition for esophageal replacement: a 10-year experience. Ann Thorac Surg. 2012 Oct;94(4):1104-11; discussion 1111-3. doi: 10.1016/j.athoracsur.2012.05.123. Epub 2012 Aug 29. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kim J, Oh BM, Kim JY, Lee GJ, Lee SA, Han TR. Validation of the videofluoroscopic dysphagia scale in various etiologies. Dysphagia. 2014 Aug;29(4):438-43. doi: 10.1007/s00455-014-9524-y. — View Citation

Konradsson M, van Berge Henegouwen MI, Bruns C, Chaudry MA, Cheong E, Cuesta MA, Darling GE, Gisbertz SS, Griffin SM, Gutschow CA, van Hillegersberg R, Hofstetter W, Holscher AH, Kitagawa Y, van Lanschot JJB, Lindblad M, Ferri LE, Low DE, Luyer MDP, Ndegwa N, Mercer S, Moorthy K, Morse CR, Nafteux P, Nieuwehuijzen GAP, Pattyn P, Rosman C, Ruurda JP, Rasanen J, Schneider PM, Schroder W, Sgromo B, Van Veer H, Wijnhoven BPL, Nilsson M. Diagnostic criteria and symptom grading for delayed gastric conduit emptying after esophagectomy for cancer: international expert consensus based on a modified Delphi process. Dis Esophagus. 2020 Apr 15;33(4):doz074. doi: 10.1093/dote/doz074. — View Citation

Lagergren P, Fayers P, Conroy T, Stein HJ, Sezer O, Hardwick R, Hammerlid E, Bottomley A, Van Cutsem E, Blazeby JM; European Organisation for Research Treatment of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago-gastric junction and the stomach. Eur J Cancer. 2007 Sep;43(14):2066-73. doi: 10.1016/j.ejca.2007.07.005. Epub 2007 Aug 15. — View Citation

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. — View Citation

Lee MK, Yost KJ, Pierson KE, Schrandt AJ, Skaare BJ, Blackmon SH. Standard setting for a novel esophageal conduit questionnaire: CONDUIT Report Card. J Patient Rep Outcomes. 2018 Oct 24;2(1):51. doi: 10.1186/s41687-018-0073-2. — View Citation

Low DE, Alderson D, Cecconello I, Chang AC, Darling GE, D'Journo XB, Griffin SM, Holscher AH, Hofstetter WL, Jobe BA, Kitagawa Y, Kucharczuk JC, Law SY, Lerut TE, Maynard N, Pera M, Peters JH, Pramesh CS, Reynolds JV, Smithers BM, van Lanschot JJ. International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy: Esophagectomy Complications Consensus Group (ECCG). Ann Surg. 2015 Aug;262(2):286-94. doi: 10.1097/SLA.0000000000001098. — View Citation

Luan A, Hunter CL, Crowe CS, Lee GK. Comparison of Outcomes of Total Esophageal Reconstruction With Supercharged Jejunal Flap, Colonic Interposition, and Gastric Pull-up. Ann Plast Surg. 2018 May;80(5S Suppl 5):S274-S278. doi: 10.1097/SAP.0000000000001471. — View Citation

Mahajan NN, Lee MK, Yost KJ, Pierson KE, Viehman JK, Allen MS, Cassivi SD, Nichols FC, Reisenauer JS, Shen KR, Wigle DA, Blackmon SH. Preliminary Normative Standards of the Mayo Clinic Esophagectomy CONDUIT Tool. Mayo Clin Proc Innov Qual Outcomes. 2019 Nov 22;3(4):429-437. doi: 10.1016/j.mayocpiqo.2019.07.008. eCollection 2019 Dec. — View Citation

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. — View Citation

O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia. 1999 Summer;14(3):139-45. doi: 10.1007/PL00009595. — View Citation

Ochsner A, Owens N. Anterothoracic Oesophagoplasty for Impermeable Stricture of the Oesophagus. Ann Surg. 1934 Dec;100(6):1055-91. doi: 10.1097/00000658-193412000-00002. No abstract available. — View Citation

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Schiller LR, Pardi DS, Sellin JH. Chronic Diarrhea: Diagnosis and Management. Clin Gastroenterol Hepatol. 2017 Feb;15(2):182-193.e3. doi: 10.1016/j.cgh.2016.07.028. Epub 2016 Aug 2. — View Citation

Stephens EH, Gaur P, Hotze KO, Correa AM, Kim MP, Blackmon SH. Super-Charged Pedicled Jejunal Interposition Performance Compares Favorably With a Gastric Conduit After Esophagectomy. Ann Thorac Surg. 2015 Aug;100(2):407-13. doi: 10.1016/j.athoracsur.2015.03.040. Epub 2015 Jun 20. — View Citation

Yang YS, Shang QX, Yuan Y, Wu XY, Hu WP, Chen LQ. Comparison of Long-term Quality of Life in Patients with Esophageal Cancer after Ivor-Lewis, Mckeown, or Sweet Esophagectomy. J Gastrointest Surg. 2019 Feb;23(2):225-231. doi: 10.1007/s11605-018-3999-z. Epub 2018 Oct 8. — View Citation

Yasuda T, Shiozaki H. Esophageal reconstruction using a pedicled jejunum with microvascular augmentation. Ann Thorac Cardiovasc Surg. 2011;17(2):103-9. doi: 10.5761/atcs.ra.10.01648. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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	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.
Primary	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.
Secondary	Incidence of dysphagia	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)	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.