Oesophagectomy and Chest Wall and Respiratory Function

NCT ID: NCT03835273

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2025-08-31

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.

Detailed Description

The study population consists of 40 healthy volunteers who have not received upper gastrointestinal surgery and 60 patients treated with surgery more than one year ago (open approach). Chest wall movement will be measured using a 3D optical motion system and the investigators will establish if inertial measurement units placed strategically on the chest wall are able to quantify chest expansion and lung capacity. Data will be acquired during different breathing patterns and during use of an incentive spirometry. Pulmonary function tests will be undertaken in all patients and the investigators will also collect clinical data concerning health-related quality of life and other concomitant medical conditions. The target outcome of this study is to determine whether the 3D motion capture and wearable systems are reliable in the measurement of chest wall movement after surgical removal of esophagus and the validity and patient acceptability of wearable system, as well as the ability of distinguishing open and minimally invasive surgical approach. A tailored physiotherapy may be developed following this study in order to improve chest wall movement and objectively measure this using the wearable system. This can then be implemented in a clinical trial to provide the evidence base to for patient-tailored physiotherapy following major cancer surgery and to optimise the respiratory function.

Conditions

Esophageal Cancer; Esophagectomy; Respiratory Function Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

Fourty control participants who have not received upper gastrointestinal surgery.

3D motion capture system

Intervention Type: 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.

Incentive spirometry

Intervention Type: OTHER

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

Questionnaires

Intervention Type: 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.

Open surgery

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

3D motion capture system

Intervention Type: 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.

Incentive spirometry

Intervention Type: OTHER

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

Questionnaires

Intervention Type: 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.

Interventions

3D motion capture system

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.

Intervention Type: OTHER

Incentive spirometry

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

Intervention Type: OTHER

Questionnaires

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Exposure group:

1. Patients treated more than a year ago with oesophagectomy for oesophageal cancer, by an open approach.

2. Patients able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.

• Control group:

1. Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.

2. Individuals able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheraz R Markar, Dr

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Charing Cross Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sheraz R Markar, Dr

Role: CONTACT

s.markar@imperial.ac.uk

+44203312 2125

Karina Tukanova

Role: CONTACT

karina.tukanova17@imperial.ac.uk

+447751844678

Facility Contacts

Karina Tukanova, MD

Role: primary

karina.tukanova17@imperial.ac.uk

+447751844678

References

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.

Reference Type: BACKGROUND

PMID: 24250962 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8044603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22552194 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24778050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27283109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22943844 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8433390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17702567 (View on PubMed)

Other Identifiers

19SM5007

Identifier Type: -

Identifier Source: org_study_id