Frailty In Thoracic Surgery for Esophageal Cancer

NCT04145726 | Unknown

• 1 other identifier: H-16020318
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In Demark we se an increasing life expectancy and an increasing incidence of esophageal cancer and gastroesophageal junction (c.esophagus), with an average age of 65 years at diagnosis time. The consequence of this is an increased number of patients in need of esophageal resection. Esophageal cancer is currently treated with chemotherapy, radiotherapy and, whenever possible, esophageal resection. This multimodal treatment has increased survival, but is also associated with significant morbidity, mortality and adverse postoperative quality of life. At present, there is no standardized risk assessment for patients with c.esophagus who have to undergo esophageal resection. This study evaluates the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty) score, which identify patients being frail or not based on an assessment of the patient's physical condition. Purpose: Investigate how many patients that are frail undergoing esophageal resection. With the assumptions that CAF score can identify frail patients and that frail patients, have an increased risk of postoperative complications. With CAF score, we believe to become better of predicting complications following esophageal resection. Method: Prospective observational study of patients with c.esophagus undergoing esophageal resection. Plan to include 60 patients over one year period. The patients are deemed frail or not with the use of CAF score, which consist of various smaller physical test and questions. Postoperativley a follow-up after 30-days, six month and 12 month. At follow-up times, data are collected on the somatic readmissions / diagnoses and vital status. Afterwards we compare complications, mortality and quality of life in frail versus non-frail patients. Side effects, risks and disadvantages: At present, there is no standardized risk assessment used for preoperative risk assessment for patients with c.esophagus undergoing esophageal resection. The introduction of CAF score, will not expose patients to a risk or side effect, since the course or treatment does not change. Economy: We consider the study to be economically justified, since we hypothesize that this would lead to fewer readmissions, days of intensive care and shorter hospitalization. Acquisition: The patients will be 60 years or older and are undergoing esophageal resection. They will receive verbal- and written information preoperatively. At the first appearance they meet our project assistant who will answer any questions. Subsequently, the patients will be asked to sign a consent form. Publication of test results / research ethics statement: The knowledge and results gained through the research will provide essential scientific information of significans for the future course and treatment of patients undergoing esophageal resection in terms of number of hospital days, intensive days and readmissions.

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• The portion of frail patients undergoing esophageal resection and 6 -month all-cause of mortality

  Identify number of frail patients undergoing esophageal resection. The patients are deemed frail by score comprehensive assessment of frailty. 6 month all-cause mortality in frail vs. non-frail patients (hospital mortality or death within 6 month postoperatively).

  one year

Secondary Outcomes (1)

• One-year all-cause mortality in frail vs. non-frail patients One-year all-cause mortality in frail vs. non-frail patients One-year all-cause mortality in frail vs. non-frail patients

  one year

Other Outcomes (1)

• postoperatively complications in frail vs. non-frail

  one year

Study Arms (1)

Patients undergoing esophageal resection

All patients undergoing esophageal resection will be included and tested if frail or non-frail. Which means there is no intervention

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective observational study of patients with c.esophagus undergoing esophageal resection at department of Thoracic Surgery and Abdominal Surgery, Rigshospitalet, University of Copenhagen, Denmark. Expect to include 60 patients over a period of 1 year. With a follow-up of minimum 12 month.

You may qualify if:

• All patients aged 60 years or older
• Diagnosed with esophageal cancer being squamous-cell carcinoma or adenocarcinoma
• Referred to esophageal resection

You may not qualify if:

• Not Danish speaking. Need of an interpreter
• Severe neuropsychiatric impairment
• Not cooperative (psychiatric diagnosis)
• Earlier esophageal resection

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

RECRUITING

Related Publications (10)

• Beckert AK, Huisingh-Scheetz M, Thompson K, Celauro AD, Williams J, Pachwicewicz P, Ferguson MK. Screening for Frailty in Thoracic Surgical Patients. Ann Thorac Surg. 2017 Mar;103(3):956-961. doi: 10.1016/j.athoracsur.2016.08.078. Epub 2016 Oct 6.

  PMID: 27720368 BACKGROUND

• Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Allen C, Barber RM, Barregard L, Bhutta ZA, Brenner H, Dicker DJ, Chimed-Orchir O, Dandona R, Dandona L, Fleming T, Forouzanfar MH, Hancock J, Hay RJ, Hunter-Merrill R, Huynh C, Hosgood HD, Johnson CO, Jonas JB, Khubchandani J, Kumar GA, Kutz M, Lan Q, Larson HJ, Liang X, Lim SS, Lopez AD, MacIntyre MF, Marczak L, Marquez N, Mokdad AH, Pinho C, Pourmalek F, Salomon JA, Sanabria JR, Sandar L, Sartorius B, Schwartz SM, Shackelford KA, Shibuya K, Stanaway J, Steiner C, Sun J, Takahashi K, Vollset SE, Vos T, Wagner JA, Wang H, Westerman R, Zeeb H, Zoeckler L, Abd-Allah F, Ahmed MB, Alabed S, Alam NK, Aldhahri SF, Alem G, Alemayohu MA, Ali R, Al-Raddadi R, Amare A, Amoako Y, Artaman A, Asayesh H, Atnafu N, Awasthi A, Saleem HB, Barac A, Bedi N, Bensenor I, Berhane A, Bernabe E, Betsu B, Binagwaho A, Boneya D, Campos-Nonato I, Castaneda-Orjuela C, Catala-Lopez F, Chiang P, Chibueze C, Chitheer A, Choi JY, Cowie B, Damtew S, das Neves J, Dey S, Dharmaratne S, Dhillon P, Ding E, Driscoll T, Ekwueme D, Endries AY, Farvid M, Farzadfar F, Fernandes J, Fischer F, G/Hiwot TT, Gebru A, Gopalani S, Hailu A, Horino M, Horita N, Husseini A, Huybrechts I, Inoue M, Islami F, Jakovljevic M, James S, Javanbakht M, Jee SH, Kasaeian A, Kedir MS, Khader YS, Khang YH, Kim D, Leigh J, Linn S, Lunevicius R, El Razek HMA, Malekzadeh R, Malta DC, Marcenes W, Markos D, Melaku YA, Meles KG, Mendoza W, Mengiste DT, Meretoja TJ, Miller TR, Mohammad KA, Mohammadi A, Mohammed S, Moradi-Lakeh M, Nagel G, Nand D, Le Nguyen Q, Nolte S, Ogbo FA, Oladimeji KE, Oren E, Pa M, Park EK, Pereira DM, Plass D, Qorbani M, Radfar A, Rafay A, Rahman M, Rana SM, Soreide K, Satpathy M, Sawhney M, Sepanlou SG, Shaikh MA, She J, Shiue I, Shore HR, Shrime MG, So S, Soneji S, Stathopoulou V, Stroumpoulis K, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tadese F, Tedla BA, Tessema GA, Thakur JS, Tran BX, Ukwaja KN, Uzochukwu BSC, Vlassov VV, Weiderpass E, Wubshet Terefe M, Yebyo HG, Yimam HH, Yonemoto N, Younis MZ, Yu C, Zaidi Z, Zaki MES, Zenebe ZM, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017 Apr 1;3(4):524-548. doi: 10.1001/jamaoncol.2016.5688.

  PMID: 27918777 BACKGROUND

• Murray P, Whiting P, Hutchinson SP, Ackroyd R, Stoddard CJ, Billings C. Preoperative shuttle walking testing and outcome after oesophagogastrectomy. Br J Anaesth. 2007 Dec;99(6):809-11. doi: 10.1093/bja/aem305. Epub 2007 Oct 24.

  PMID: 17959592 BACKGROUND

• Chen CH, Ho-Chang, Huang YZ, Hung TT. Hand-grip strength is a simple and effective outcome predictor in esophageal cancer following esophagectomy with reconstruction: a prospective study. J Cardiothorac Surg. 2011 Aug 15;6:98. doi: 10.1186/1749-8090-6-98.

  PMID: 21843340 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Robinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598.

  PMID: 19730176 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.

  PMID: 20627611 BACKGROUND

• Back C, Hornum M, Olsen PS, Moller CH. 30-day mortality in frail patients undergoing cardiac surgery: the results of the frailty in cardiac surgery (FICS) copenhagen study. Scand Cardiovasc J. 2019 Dec;53(6):348-354. doi: 10.1080/14017431.2019.1644366. Epub 2019 Jul 23.

  PMID: 31304801 BACKGROUND

• Sundermann S, Dademasch A, Rastan A, Praetorius J, Rodriguez H, Walther T, Mohr FW, Falk V. One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form. Interact Cardiovasc Thorac Surg. 2011 Aug;13(2):119-23; discussion 123. doi: 10.1510/icvts.2010.251884. Epub 2011 Mar 4.

  PMID: 21378017 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Caroline Bäck

CONTACT

004528912312; anne.caroline.bck@regionh.dk

Mette Siemsen

CONTACT

mette.siemsen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medical Science, Principal investigator

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: September 25, 2019
• Primary Completion: October 31, 2020
• Study Completion: April 30, 2022
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

DK (1)