Clinical trial NCT03835273: Oesophagectomy and Chest Wall and Respiratory Function
Official title: Changes in Respiratory Function and Chest Wall Movement Following Oesophagectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Esophagectomy
Respiratory Function Loss
Keywords: Esophagectomy
Motion capture
Respiratory
Oesophageal cancer
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three cohorts will be studied, equal in size. A total of 150 patients will be included in this study. One hundred patients who have undergone oesophagectomy for oesophageal cancer more than a year ago, 50 patients who have undergone open surgery and 50 who have undergone a minimally invasive approach. In addition, 50 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.

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 50 healthy volunteers who have not received upper gastrointestinal surgery and 100 patients treated with surgery more than one year ago (50 open and 50 minimally invasive). 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.

Eligibility criteria: Inclusion Criteria:

* Exposure group:

  1. Patients treated more than a year ago with oesophagectomy for oesophageal cancer, either by an open approach or minimally invasive surgery.
  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.

Primary outcomes:
measure: Chest wall movement
timeFrame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
measure: Lung function
timeFrame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Secondary outcomes:
measure: Health-related Quality of Life in cancer patients
timeFrame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
measure: Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach
timeFrame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Other outcomes:
measure: Usability and acceptability of the measuring device
timeFrame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Sheraz R Markar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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.