Oesophagectomy and Chest Wall and Respiratory Function

NCT03835273 | Recruiting

• 1 other identifier: 19SM5007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%). Minimally invasive approach through keyhole surgery has been shown to reduce pulmonary infections by 20%. Enhanced recovery programmes are evidence-based protocols, developed to achieve early recovery after surgery with early mobilisation and chest physiotherapy and have been shown to reduce pulmonary complication rates as well. The investigators intend to objectively measure chest wall movement using 3D motion capture system as well as a wearable measurement system to monitor chest wall movement.

Conditions

Esophageal Cancer; Esophagectomy; Respiratory Function Loss

Keywords

Esophagectomy; Motion capture; Respiratory; Oesophageal cancer

Outcome Measures

Primary Outcomes (2)

• Chest wall movement

  Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open surgery) and in healthy control participants. Reflective markers will be placed on the chest wall of the participant and chest wall movement will be detected by a 3D motion capture system using these markers. In addition, inertia measurement units will be applied next to the markers. Chest wall movement will be assessed during normal breathing, take and hold a deep breath and whilst performing incentive spirometry.

  Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.

• Lung function

  Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. Spirometry (tidal breathing, forced vital capacity) and respiratory muscle strength will be recorded for all participants.

  Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.

Secondary Outcomes (2)

• Health-related Quality of Life in cancer patients

  Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.

• Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach

  Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.

Other Outcomes (1)

• Usability and acceptability of the measuring device

  Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.

Study Arms (2)

Control group

Fourty control participants who have not received upper gastrointestinal surgery.

Other: 3D motion capture system; Other: Incentive spirometry; Other: Questionnaires

Open surgery

Sixty patients who have undergone open removal of oesophagus more than one year ago.

Other: 3D motion capture system; Other: Incentive spirometry; Other: Questionnaires

Interventions

3D motion capture system OTHER

Small reflective markers and inertia measurement units will be placed on the chest of the patients using hypoallergenic adhesive and a motion capture system will pick up a 3D image via these markers non-invasively.

Control group; Open surgery

Incentive spirometry OTHER

Incentive spirometry is a non-invasive device for assessment of pulmonary function.

Control group; Open surgery

Questionnaires OTHER

Three validated, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Oesophago-Gastric Module 25 (EORTC QLQ-OG25) and LASORS questionnaire.

Control group; Open surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three cohorts will be studied, equal in size. A total of 100 patients will be included in this study. One hundred patients who have undergone oesophagectomy for oesophageal cancer more than a year ago, 60 patients who have undergone open surgery and 40 healthy volunteers will be included as a control group with no underlying respiratory disease and no previous history of upper gastrointestinal surgery. Patients who have undergone oesophagectomy will be identified from existing databases by the direct care team of the patient. Healthy volunteers will be recruited from Imperial College through paper adverts.

You may qualify if:

• Exposure group:
• Patients treated more than a year ago with oesophagectomy for oesophageal cancer, by an open approach.
• Control group:
• Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.

You may not qualify if:

• Any participant who lacks capacity or is unable to provide informed consent.
• Any participant younger than 18 or older than 90 years of age.
• Any patient with evidence of cancer recurrence or on-going postoperative complication at more than one year following surgery for oesophageal cancer.
• Any pregnant participant.
• unable to or excluded from performing spirometry or respiratory muscle strength testing (non-invasive testing)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

RECRUITING

Related Publications (8)

• Shirinzadeh A, Talebi Y. Pulmonary Complications due to Esophagectomy. J Cardiovasc Thorac Res. 2011;3(3):93-6. doi: 10.5681/jcvtr.2011.020. Epub 2011 Aug 20.

  PMID: 24250962 BACKGROUND

• Nagawa H, Kobori O, Muto T. Prediction of pulmonary complications after transthoracic oesophagectomy. Br J Surg. 1994 Jun;81(6):860-2. doi: 10.1002/bjs.1800810622.

  PMID: 8044603 BACKGROUND

• Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.

  PMID: 22552194 BACKGROUND

• Kubo N, Ohira M, Yamashita Y, Sakurai K, Toyokawa T, Tanaka H, Muguruma K, Shibutani M, Yamazoe S, Kimura K, Nagahara H, Amano R, Ohtani H, Yashiro M, Maeda K, Hirakawa K. The impact of combined thoracoscopic and laparoscopic surgery on pulmonary complications after radical esophagectomy in patients with resectable esophageal cancer. Anticancer Res. 2014 May;34(5):2399-404.

  PMID: 24778050 BACKGROUND

• Schmidt HM, El Lakis MA, Markar SR, Hubka M, Low DE. Accelerated Recovery Within Standardized Recovery Pathways After Esophagectomy: A Prospective Cohort Study Assessing the Effects of Early Discharge on Outcomes, Readmissions, Patient Satisfaction, and Costs. Ann Thorac Surg. 2016 Sep;102(3):931-939. doi: 10.1016/j.athoracsur.2016.04.005. Epub 2016 Jun 7.

  PMID: 27283109 BACKGROUND

• Li C, Ferri LE, Mulder DS, Ncuti A, Neville A, Lee L, Kaneva P, Watson D, Vassiliou M, Carli F, Feldman LS. An enhanced recovery pathway decreases duration of stay after esophagectomy. Surgery. 2012 Oct;152(4):606-14; discussion 614-6. doi: 10.1016/j.surg.2012.07.021. Epub 2012 Sep 1.

  PMID: 22943844 BACKGROUND

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• 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.

  PMID: 17702567 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sheraz R Markar, Dr

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheraz R Markar, Dr

CONTACT

+44203312 2125; s.markar@imperial.ac.uk

Karina Tukanova

CONTACT

+447751844678; karina.tukanova17@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: May 29, 2019
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)