3. Secondary outcomes.
| Study | Cancer‐free survival | Treatment failures | Procedure‐related mortality (30 day) | Complications | QoL | |||||
| Treatment group | Endoscopic treatment | Surgical treatment | Endoscopic treatment | Surgical treatment | Endoscopic treatment | Surgical treatment | Endoscopic treatment | Surgical treatment | Endoscopic treatment | Surgical treatment |
| Pacifico 2003 | 83% (20/24) remained free of cancer at 12 ± 2 and 19 ± 3 months | All patients remained free of cancer at 12 ± 2 and 19 ± 3 months | Persistent cancer at first follow‐up 17% (4/24 patients). No later recurrence | None | None | 2% | Stricture: 8% Photo‐ sensitivity: 8% |
Stricture: 16% Anastomotic leak: 8% Wound infection: 8% Dumping syndrome: 5% Empyema (pus in the pleural cavity): 3% Blood transfusion: 3% Atrial fibrillation: 3% Aspiration: 2% Chylothorax (lymphatic effusion in the pleural cavity): 2% |
Not reported | |
| Prasad 2007 | No significant difference between groups but tendency towards lower cancer‐free survival in endoscopic therapy group | HGD eliminated: at 1 year: 88%; at 3 years: 86% HGD detected within 12 months: 26% (33/129) i.e. failed initial therapy and retreated, HGD eradicated in 70% of these. Recurrence of HGD (detected after 12 months free of HGD): 7.8% (10/129) Cancer detected during follow‐up (up to 18 months after PDT): 6.2% (8/129) |
None | None | 1.4% | No early complications Stricture formation: 27% Photosensitivity: 60% |
38% Postoperative morbidity Stricture formation: 12.6% |
No QoL data, performance score only given ECOG PS?1 in 73% at end of FU* Proportions unchanged from pre‐therapy |
No QoL data, performance score only given ECOG PS?1 in 94% at end of FU* Proportions unchanged from pre‐therapy |
|
| Das 2008 | (Only oesophageal cancer‐specific cause of death considered) 56 months (50 to 61 months) |
59 months (57 to 67 months) (no significant difference) | Not reported | Not reported | Not reported | Not reported | ||||
| Reed 2005 | Not reported | 5/42 PDT and 2/5 EMR patients had recurrent HGD/cancer after mean 13.5 months. 1 developed metastatic spread but 0 died during follow‐up | 3/49 patients died from recurrent disease | Not reported | 2% (cerebrovascular accident in postoperative period) | Not reported | Anastomotic leaks: 4% | Not reported | ||
| Rosmolen 2010 | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Significant bleeding: 3%, perforation: 2%, oesophageal stenosis: 31% | Symptomatic anastomotic leakage: 15 %, pulmonary problems: 30 %, serious infections: 15 % and vocal cord paralysis: 15 %. Anastomotic stenosis in 37% during follow‐up | QoL measured (SF‐36, EORTC‐QLQ‐C30, EORTC‐QLQ‐OES18 questionnaires). HADS, WOCS. Endoscopy patients reported more fear of recurrence on the WOCS than surgery patients (P = 0.003). No significant differences were found between the 2 groups on the other outcomes |
Surgery patients had significantly more eating problems (OR 18.3; P < 0.001) and reflux symptoms (OR 3.4; P = 0.05) on the EORTC‐OES18 questionnaire |
| Schembre 2008 | Not reported | Residual Barrett's segment in 44%, persistent dysplasia in 13%, progression to cancer in 6% |
Residual Barrett's segment in 3%, persistent dysplasia in 3%, no progression to cancer |
2%: 1 patient died from diverticulitis | None | Major: 8% Minor: 32% |
Major: 13% Minor: 66% (significantly different) |
Not reported | ‐ | ‐ |
| Yachimski 2008 | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported |
| Farrell 2011 | Not reported | Not reported | In patients treated by EMR + RFA, there was 100% disease control; 72% had complete eradication of Barrett's disease, and 1 patient represented with low‐grade dysplasia |
4.8% surgical patients relapsed with HGD or cancer and 1 patient with T1N1 disease died of recurrent disease | Unclear from study report | Unclear from study report | 2% mortality and 32% morbidity | 2% morbidity from EMR + RFA (statistically significant compared with surgery P=0.001) | Not reported | Not reported |
| Pech 2011 | 98.7% at 4.1 years | 100% at 3.7 years | 6.6% (repeat endoscopic treatment was successful in all patients who experienced disease recurrence | No deaths from tumour‐related disease during follow‐up | None | Mortality at 40 days 2.6% | Minor complication in 17% (bleeding managed by clipping or injection). No major complications (severe bleeding, perforation stenosis) observed | 32% major complications. including anastomotic leakage, pneumonia, multiple organ failure following sepsis, cardiac problems | Not reported | Not reported |
| Schembre 2010 | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | SF‐36: no significant differences compared with surgery GIQLI: higher (better) scores among ASA Class 1 and 2 endotherapy patients compared with surgery (not statistically significant) and higher among young endotherapy patients than young surgery patients |
SF‐36: no significant differences other than superior physical functioning in patients 65 years of age and older GIQLI: no significant differences in scores of older patients for surgery and endotherapy or SAS 3 patients. Negative QoL impact appears to be greater for younger patients undergoing surgery. (overall QoL scores: "QOL scores among EG and ET groups were not significantly different than sex age‐matched controls” |
| Tian 2011 | Not reported | Not reported | In group who had EMR as only therapy, 21.4% had cancer recurrence at 45 months follow‐up (remaining 11 had mean cancer‐free periods of 21 months) | Not reported | None | 1 death at 34 days owing to anastomotic leak (with 'do not resuscitate' order) | Not reported | Not reported | Not reported | Not reported |
| Thomas 2005 | Not reported | Not reported | 2/5 went on to develop metastatic adenocarcinoma at 9 and 12 months follow‐up | 2/8 patients developed recurrent adenocarcinoma at 22 and 60 months after surgery, 1 of whom died | None | None | Postoperative morbidity in 4 patients (pneumonia, adult respiratory distress syndrome, pneumothorax) 2/8 developed postoperative strictures at 3 to 6 months' postsurgery requiring ongoing dilation | Not reported | Not reported | Not reported |
| Zehetner 2011 | 100% at 3 years; 100% at 5 years |
100% at 3 years; 88% at 5 years |
20% had new or metachronous cancer | None | None | None | None reported | 39% had complications including long‐term complications of anastomotic strictures, ventral hernias, reflux, postprandial dumping or diarrhoea | Not reported | Not reported |
*ECOG PS 0 = fully active, able to carry on all pre‐disease performance without restriction.
ECOG PS 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
ASA: American Society of Anesthesia; EMR: endoscopic mucosal resection; EORTC‐QLQ: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; FU: fluorouracil; GIQLI: Gastrointestinal Quality of Life Index; HADS: Hospital Anxiety and Depression Scale; OR: odds ratio; PDT: photodynamic therapy; QoL: quality of life; RFA: radiofrequency ablation; SF‐36: 36‐item Short Form; WOCS: Worry Of Cancer Scale.