Interventional procedure consultation document

Minimally invasive oesophagectomy for cancer or high-grade dysplasia of the oesophagus

Treating cancer or pre-cancerous lesions of the oesophagus by keyhole surgery to remove all or part of the oesophagus

In minimally invasive oesophagectomy, all or part of the oesophagus (gullet) is removed and the stomach joined to the upper oesophagus. The operation is usually done because of cancer, but may also be done in patients with pre-cancerous lesions (high-grade dysplasia). In some patients the oesophagus can be removed using a camera and keyhole surgical instruments inserted into the chest and/or the abdomen.

The National Institute for Health and Clinical Excellence (NICE) is examining minimally invasive oesophagectomy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about cancer or high-grade dysplasia of the oesophagus.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 24 June

Target date for publication of guidance: September 2011

1   Provisional recommendations

1.1  Current evidence on the efficacy and safety of minimally invasive oesophagectomy (MIO) for cancer or high-grade dysplasia of the oesophagus is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit with local review of results.

1.2  Patient selection should be done by a multidisciplinary team specialising in the management of oesophageal cancer.

1.3  MIO is a technically challenging procedure, which should only be carried out by surgeons with special expertise and specific training. They should perform their initial operations with an experienced mentor.

1.4  Clinicians should enter details about all patients undergoing MIO for cancer or high-grade dysplasia of the oesophagusonto the National Oesophago-gastric Cancer Audit (www.ic.nhs.uk/services/national-clinical-audit-support-programme-ncasp/cancer/oesophago-gastric).

2   The procedure

2.1  Indications and current treatments

2.1.1  Oesophagectomy is used to treat patients with resectable cancer of the oesophagus. It is also a treatment option for patients who have Barrett’s oesophagus with high-grade dysplasia. Conventionally, oesophagectomy is performed using open surgery.

2.1.2  Depending on the tumour type, location and stage, oesophagectomy may involve a total or partial resection of the oesophagus, with or without dissection of regional lymph nodes. Total oesophagectomy involves both a thoracic incision to mobilise the oesophagus and an abdominal incision to dissect and prepare the stomach (or sometimes intestine) for anastomosis to the remaining upper oesophagus or pharynx. The new gastric tube is then drawn up the chest to the level of the healthy oesophageal remnant, and an anastomosis is performed, usually via a cervical incision. In some patients (typically with lower-third tumours), partial oesophagectomy may be done transhiatally, using only an abdominal incision. There are a number of technical variations in the way the open oesophagectomy can be done.

2.2   Outline of the procedure

2.2.1  Minimally invasive oesophagectomy aims to achieve the same result as open oesophagectomy but with less postoperative morbidity.

2.2.2  The procedure is performed with the patient under general anaesthesia. Single-lung ventilation is required for the thoracic part of the operation (except for transhiatal techniques). MIO involves performing oesophagectomy under thoracoscopic and laparoscopic visualisation. However the term MIO is also applied to hybrid MIO (HMIO) techniques, which combine either thoracoscopy or laparoscopy with open surgery.

2.2.3  Thoracic and/or abdominal insufflation with carbon dioxide is used, and a number of incisions are made to accommodate camera and instrument ports. Following resection of the oesophagus, anastomosis is performed either via an (open) cervical approach, or an intrathoracic endoscopic approach using stapling devices.

2.2.4  MIO is a complex procedure and the operating time may be long.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP/326/overview

2.3  Efficacy

2.3.1  A study of routine hospital episodes statistics data compared 699 patients treated by MIO or HMIO versus 17,974 patients treated by open oesophagectomy. Based on data available for 41% (7724/18,673) of patients and after adjusting for age, gender, socioeconomic deprivation, comorbidity score, year of operation, and number of emergency hospital admissions in the previous year, there was some evidence that patients undergoing MIO or HMIO had lower 1-year mortality than patients treated by open oesophagectomy (odds ratio [OR] 0.68, 95% confidence interval [CI] = 0.46 to 1.01, p = 0.058).

2.3.2  Two non-randomised studies comparing HMIO versus open oesophagectomy reported recurrence rates of 6% (1/17) and 0% (0/14) respectively (undefined follow-up interval); and 19% (3/16) and 7% (2/28) at 44-months follow-up (significance not stated). Three non-randomised comparative studies, including in total 143 patients, 73 treated by HMIO and 70 treated by open surgery, reported recurrence rates ranging from 0% to 44% in patients treated by HMIO and from 3% to 50% in those treated by open surgery (follow-up ranging from 6 months to 54 months). Another non-randomised comparative study comparing 165 patients treated by HMIO versus 56 treated by open surgery reported no significant association between either technique and cancer recurrence (rate of recurrence: 58% for HMIO and 68% for open surgery; follow-up not stated).

2.3.3  A non-randomised comparative study comparing 27 patients treated by HMIO against 29 patients treated by open surgery assessed quality of life in 5 domains of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-OES18 questionnaires (fatigue, pain, dyspnoea, physical functioning, global quality of life). Both patient groups had similar preoperative scores. Compared with baseline, quality of life scores deteriorated in all 5 domains at 2-weeks in both groups, although the scores were worse in the open surgery group.. Over time quality of life scores improved in both groups.   At 24-week follow-up there were statistically significant differences between the two groups  for physical functioning (mean score of 84 for HMIO versus a mean score of 76 for open surgery) and global quality of life ( mean score of 75 for HMIO versus a mean score of 68 in the open surgery group).

2.3.4  The Specialist Advisers considered key efficacy outcomes to include speed of postoperative recovery compared with open surgery, cancer recurrence, overall survival, quality of life, and more frequent need for cervical anastomosis compared with open surgery.

2.4   Safety

2.4.1  Thirty-day in-hospital mortality was reported as 2% (1/50) in patients treated by MIO and 3% (1/30) in patients treated by open surgery in a non-randomised comparative study of 80 patients. Two non-randomised comparative studies comparing 15 and 18 patients treated by MIO with 30 and 36 patients treated by open surgery, respectively, reported no in-hospital deaths within 30 days of the procedure. A non-randomised comparative study of 90 patients reported 30-day in-hospital mortality of 7% (3/44) after MIO and 4% (2/46) after open oesophagectomy.

2.4.2  Two non-randomised comparative studies reported 30-day in-hospital mortality of 2% (1/45) and 5% (1/22) in patients treated by HMIO, while no deaths were reported in the 26 and 63 patients treated by open oesophagectomy. Six non-randomised comparative studies comparing a total of 475 patients treated by MIO versus 434 treated by open surgery reported that 30-day in-hospital mortality was higher after open surgery (10% versus 14%, 6% versus 11%, 0% versus 5%, 0% versus 7%, 3% versus 6%, and 3% versus 8%; significance not stated).  

2.4.3  Two non-randomised comparative studies reported 30-day in-hospital mortality of 5% (1/22) and 4% (2/56) in patients treated by MIO or HMIO, and 6% (3/43) or 9% (9/98) in those treated by open oesophagectomy (follow-up and significance level not stated).

2.4.4  In the study of routine hospital episodes statistics data comparing 699 patients treated by MIO or HMIO versus 17,974 patients treated by open oesophagectomy, and based on data available for 49% [9217/18,673] of patients, after adjusting for age, gender, socioeconomic deprivation, comorbidity score, year of operation, and number of emergency hospital admissions in the previous year, there was no significant difference between the comparator groups for 30-day in-hospital mortality (OR = 0.99, 95% CI = 0.68 to 1.44, p = 0.936).

2.4.5  A non-randomised comparative study of 41 patients treated by MIO, 34 by HMIO or 46 by open surgery reported 30-day in-hospital mortalities of 2%, 6% and 2% respectively. A non-randomised comparative study of 23 patients treated by MIO, 309 by HMIO or 114 by open surgery reported 30-day in-hospital mortalities of 0%, 2% and 3% respectively.

2.4.6  Anastomotic leakage rates ranged from 0% to 20% among patients treated by either MIO or HMIO, and from 2% to 29% among patients treated by open surgery in 21 non-randomised comparative studies (total number of patients: 1371 MIO or HMIO, 1114 open). Among patients with anastomotic leakage, rates of reoperation ranged from 0% to 19% in patients treated by MIO or HMIO and from 0% to 26% in patients treated by open surgery in all but 1 study, which reported a 76% reoperation rate for open surgery patients. Case series of 222 and 282 patients reported that 12% (26/222) and 13% (36/282) of patients developed an anastomotic leak.

2.4.7  Tracheal perforation occurred in 5% (1/22) and 0% (0/21) of patients treated by HMIO and in 13% (8/63) and 5% (1/21) of patients treated by open surgery in two non-randomised comparative studies. Intraoperative tracheal perforation (described as minor) occurred in less than 1% (2/222) of patients in a case series. Tracheal tear occurred in 2 patients in each of 2 case series (222 and 282 patients).

2.4.8  Damage to adjacent organs (not otherwise specified) occurred in 0% to 8% of patients treated by MIO or HMIO and in 0% to 15% of patients treated by open surgery in 5 non-randomised comparative studies (total number of patients: 157 MIO or HMIO, 176 open). One case report described injury to the supradiaphragmatic aorta during the laparoscopic phase of an oesophagectomy requiring conversion to open surgery; another case report described injury to an aberrant right subclavian artery during thoracoscopic mobilisation of the oesophagus which was successfully repaired.

2.4.9  Tension capnothorax was described in 1 case report, requiring conversion to open surgery.

2.4.10  Chyle leakage rates ranged from 0% to 9% in patients treated by MIO or HMIO and 0% to 7% in patients treated by open surgery in 11 non-randomised comparative studies (total number of patients: 752 MIO or HMIO, 525 open). Two case series reported chylothorax in 3% (7/222) and 3% (7/282) of patients.

2.4.11  Laryngeal nerve or vocal cord damage rates ranged from 0% to 33% in patients treated by MIO or HMIO and 0% to 42% in patients treated by open surgery in 17 non-randomised comparative studies (total number of patients: 965 MIO or HMIO, 757 open). The case series of 222 patients reported vocal cord palsy in 4% (8/222) of patients. The case series of 282 patients reported recurrent laryngeal nerve injury in 5% (15/282) of patients.

2.4.12  The Specialist Advisers considered anecdotal adverse events to include major intrathoracic bleeding, damage to vital structures, and injury to the trachea and bronchi during thoracoscopic dissection and gastric necrosis.

2.5   Other comments

2.5.1  The Committee noted the possibility of bias and confounding within the published studies. However, the studies included large numbers of patients and showed no consistent differences in any efficacy or safety outcomes compared with open surgery.

3   Further information

3.1  For related NICE guidance see www.nice.org.uk 

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

May 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}