scholarly journals Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Michael Tachezy ◽  
Seung-Hun Chon ◽  
Isabel Rieck ◽  
Marcus Kantowski ◽  
Hildegard Christ ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Anastomotic Leak ◽  
Vacuum Therapy ◽  
Phase 2 ◽  
Anastomotic Leaks ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Endoscopic Vacuum Therapy ◽  
Eortc Qlq

Abstract Background Intrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT). Up to date, there is no prospective data concerning the optimal endoscopic treatment strategy. This is a protocol description for the ESOLEAK trial, which is a first small phase 2 randomized trial evaluating the quality of life after treatment of anastomotic leaks by either SEMS placement or EVT. Methods This phase 2 randomized trial will be conducted at two German tertiary medical centers and include a total of 40 patients within 2 years. Adult patients with histologically confirmed esophageal cancer, who have undergone Ivor Lewis esophagectomy and show an esophagogastric anastomotic leak on endoscopy or present with typical clinical signs linked to an anastomotic leak, will be included in our study taking into consideration the exclusion criteria. After endoscopic verification of the anastomotic leak, patients will be randomized in a 1:1 ratio into two treatment groups. The intervention group will receive EVT whereas the control group will be treated with SEMS. The primary endpoint of this study is the subjective quality of life assessed by the patient using a systematic and validated questionnaire (EORTC QLQ C30, EORTC QLQ-OES18 questionnaire). Important secondary endpoints are healing rate, period of hospitalization, treatment-related complications, and overall mortality. Discussion The latest meta-analysis comparing implantation of SEMS with EVT in the treatment of esophageal anastomotic leaks suggested a higher success rate for EVT. The ESOLEAK trial is the first study comparing both treatments in a prospective manner. The aim of the trial is to find suitable endpoints for the treatment of anastomotic leaks as well as to enable an adequate sample size calculation and evaluate the feasibility of future interventional trials. Due to the exploratory design of this pilot study, the sample size is too small to answer the question, whether EVT or SEMS implantation represents the superior treatment strategy. Trial registration ClinicalTrials.gov NCT03962244. Registered on May 23, 2019. DRKS-ID DRKS00007941

P13 DIFFERENCE IN LONG-TERM QUALITY OF LIFE BETWEEN MCKEOWN AND IVOR LEWIS ESOPHAGECTOMY

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
E Jezerskyte ◽  
L M Saadeh ◽  
E R C Hagens ◽  
M A G Sprangers ◽  
L Noteboom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Significant Difference ◽  
Cardia Carcinoma ◽  
Eortc Qlq ◽  
Mckeown Esophagectomy

Abstract Aim The purpose of this study was to investigate the difference in long-term health-related quality of life (HR-QoL) between McKeown and Ivor Lewis esophagectomy in a tertiary referral center. Background & Methods The therapy of esophageal cancers consist of (neo)adjuvant chemo(radio)therapy and surgery. Often different surgical approaches are possible such as transthoracic esophagectomy with a cervical anastomosis (McKeown) or an intrathoracic anastomosis (Ivor Lewis). Evidence is scarce on whether either of these approaches is better in terms of survival, perioperative morbidity, pathology results and quality of life. Patients with mid-, distal esophageal, gastroesophageal (GEJ) or cardia carcinoma who have undergone a McKeown or an Ivor lewis esophagectomy in the period of 2003 – 2018 were included in this study. EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires were handed out during the outpatient clinic visits and a follow-up of at least one year was ensured. Problems with eating, reflux and nausea and vomiting were chosen as primary HR-QoL domain endpoints while the remaining HR-QoL domains, postoperative complications and pathology results were observed as secondary endpoints. Correction for confounders age and gender was performed. Results 147 patients were included in the McKeown group and 120 in the Ivor Lewis group. Mean age was 63.5 years and median follow-up was three years (range 12-137 months). No significant difference was found in problems with eating, reflux and nausea and vomiting. Significantly more problems with eating with others were found in McKeown group (β=10.435, 95% CI 4.474 – 16.395) and anastomotic leakage was significantly more common after McKeown esophagectomy (p=0.004). No significant difference was found in Clavien Dindo classification. During Ivor Lewis esophagectomy significantly more lymph nodes were resected (p<0.001). Number of lymph node metastases and R0 resection rate did not differ between groups. Conclusion No major differences in long-term HR-QoL were found in patients with mid-, distal esophageal, GEJ or cardia carcinoma following McKeown or Ivor Lewis esophagectomy. Problems with eating with others and anastomotic leakages were more common after McKeown esophagectomy, however, Clavien Dindo classification and radicality of surgery were similar between the two groups. Results of this study could assist the patient during the decision-making process prior to the surgery.

scholarly journals Long-Term Quality of Life After Total Gastrectomy Versus Ivor Lewis Esophagectomy

2019 ◽  
Vol 44 (3) ◽  
pp. 838-848 ◽  
Author(s):  
E. Jezerskyte ◽  
L. M. Saadeh ◽  
E. R. C. Hagens ◽  
M. A. G. Sprangers ◽  
L. Noteboom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postoperative Complications ◽  
Lymph Nodes ◽  
Total Gastrectomy ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Eortc Qlq

Abstract Background There is scarce evidence on whether a total gastrectomy or an Ivor Lewis esophagectomy is preferred for gastroesophageal junction (GEJ) cancers regarding effects on morbidity, pathology, survival and health-related quality of life (HR-QoL). The aim of this study was to investigate the difference in long-term HR-QoL in patients undergoing total gastrectomy versus Ivor Lewis esophagectomy in a tertiary referral center. Methods Patients with a follow-up of >1 year after a total gastrectomy or an Ivor Lewis esophagectomy for GEJ/cardia carcinoma completed the EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires. ‘Problems with eating,’ ‘reflux,’ and ‘nausea and vomiting’ were the primary HR-QoL endpoints. The secondary endpoints were the remaining HR-QoL domains, postoperative complications and pathology results. Results Thirty patients after gastrectomy and 71 after esophagectomy were included. Mean age was 63 years. Median follow-up was 2 years (range 12–84 months). Patients after gastrectomy reported less ‘choking when swallowing’ and ‘coughing’ (β = − 5.952, 95% CI − 9.437 to − 2.466; β = − 13.084, 95% CI − 18.525 to − 7.643). More lymph nodes were resected in esophagectomy group (p = 0.008). No difference was found in number of positive lymph nodes, R0 resection or postoperative complications. Conclusions After a follow-up of >1 year ‘choking when swallowing’ and ‘coughing’ were less common after a total gastrectomy. No differences were found in postoperative complications or radicality of surgery. Based on this study, no general preference can be given to either of the procedures for GEJ cancer. These results support shared decision making when a choice between the two treatment options is possible.

FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4097-4097
Author(s):  
Juan W. Valle ◽  
Antoine Hollebecque ◽  
Junji Furuse ◽  
Lipika Goyal ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Global Health Status ◽  
Phase 2 ◽  
Life Data ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Eq Vas

4097 Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778. [Table: see text]

PS01.135: PROGNOSTIC ANALYSIS OF TLE-CHEST SURGERY IN ESOPHAGEAL CANCER

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 88-88
Author(s):  
Renquan Zhang ◽  
Yunlong Huang
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Esophageal Cancer ◽  
Tumor Size ◽  
Operative Time ◽  
Ivor Lewis ◽  
Total Operative Time ◽  
Ivor Lewis Esophagectomy ◽  
The Mean

Abstract Background Esophageal cancer was the ninth most common malignant tumor and ranked sixth for death globally, especially in developing country[1]. Standardized esophagectomy followed by chemotherapy or chemoradiotherapy remains the curative treatment for esophageal cancer[2]. Ivor Lewis esophageal resection, including two-stage approach for carcinoma of the middle third of the esophagus, was proposed in 1946[3]. Meanwhile, to avoid the risk of anastomotic leakage in Ivor Lewis surgery, three-stage approach with cervical anastomosis was introduced by McKeown[4]. However, considering the less complications of minimally invasive Ivor Lewis esophagectomy and the increased incidence of distal esophageal and gastroesophageal junction adenocarcinoma, two-stage approach with intrathoracic anastomosis was gaining more attention. Recent years, thoracoscopic laparoscopic esophagectomy with intrathoracic anastomosis (TLE-chest) has gradually become the mainstream approach of minimally invasive Ivor Lewis esophagectomy for the treatment of middle and lower esophageal cancers. In the previous study, we described the technique strategies of TLE-chest, which was featured with improved anastomosis layer by layer and embedding of the anastomosis with preserved mediastinal pleura[5]. In this study, we presented the perioperative data, complications and long-term survivals of TLE-chest in esophageal cancers. Methods The clinical data of 201 patients, who underwent TLE-chest for primary esophageal cancer in the First Affiliated Hospital of Anhui Medical University (FAHAMU) from November 2011 to December 2015, was analyzed retrospectively. Postoperative patients’ life quality by the European Organization into Research and Treatment of Cancer (EORTC) quality of life questionnaire for esophageal cancer and overall survivals were analyzed using Kaplan–Meier curve. The normal distribution of the measured data is expressed in terms of x ± s. Cox's hazard regression model was used for single factor and multi-factor analysis. Results Overall, 168 (83.6%) patients were males and 33 (16.4%) were females. The mean age of patients was 62.7 years old (range from 40 to 88). 150 (74.6%) patients’ tumors were located in the middle of esophagus, whereas 50 (24.9%) and 1 (0.5%) tumors were in the low and up. 194 (96.5%) esophageal tumors were confirmed as squamous carcinoma expect 7 (3.5%) adenocarcinomas. The mean of tumor size was 3.7 cm and the numbers of postoperative pathological TNM classification I, II, III and IV were 38 (18.9%), 72 (35.8%), 73 (36.3%) and 18 (9%) respectively. The average of total operation time was 293.9 min. Among them, the means of VATS and LS time were 156.9 min and 116.5 min respectively. The mean of intraoperative blood loss was 77.5 ml. The number of resected lymph nodes was 22.9 ± 9.7 (maximum: 58).7 (3.5%) patients suffered from anastomotic fistula, 5 (2.5%) patients occurred RRLN injury in lymph nodes dissection and 5 (2.5%) suffered chylothorax. Pulmonary complications were observed in 21 (10.4%) patients. Meanwhile, the rates of other complications containing anastomotic stenosis, bleeding and delayed gastric empty were 0.5% (1/201), 1.5% (3/201) and 0.5% (1/201) respectively. The score of quality of patients’ life was 85 ± 6.5. And at the 12 months, quality of life was improved by 4.1%. Until up to the 24 months, patients’ quality of life was recovered to 90 ± 7.5. The 1, 2 and 3 years overall survival of 100 patients was 94%, 79% and 74% respectively. Univariate analysis showed that the pT stage (P = 0.040), pN stage (P = 0.001), pTNM stage(P = 0.001) and Total operative time(P = 0.000) were associated with 3-year overall survival (3-OS). Further, multivariate analysis affirmed that the operative time (≥ 311 min), tumor size (≥ 3.5 cm) and pTNM stage were independent prognostic factors for 3-OS (P < 0.05). Conclusion TLE-chest surgery in esophageal cancer was safe and effective. And the total operative time, tumor size and TNM stage could be used as independent prognostic indicators in esophageal cancer patients after the TLE-chest. Disclosure All authors have declared no conflicts of interest.

P12 LONG-TERM QUALITY OF LIFE AFTER TOTAL GASTRECTOMY VERSUS IVOR LEWIS ESOPHAGECTOMY

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
E Jezerskyte ◽  
L M Saadeh ◽  
E R C Hagens ◽  
M A G Sprangers ◽  
L Noteboom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postoperative Complications ◽  
Total Gastrectomy ◽  
Nausea And Vomiting ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Significant Difference

Abstract Aim The aim of this study was to investigate the difference in long-term health-related quality of life in patients undergoing total gastrectomy versus Ivor Lewis esophagectomy in a tertiary referral center. Background & Methods Surgical treatment for gastroesophageal junction (GEJ) cancers is challenging. Both a total gastrectomy and an esophagectomy can be performed. Which of the two should be preferred is unknown given the scarce evidence regarding effects on surgical morbidity, pathology, long-term survival and health-related quality of life (HR-QoL). From 2014 to 2018, patients with a follow-up of > 1 year after either a total gastrectomy or an Ivor Lewis esophagectomy for GEJ or cardia carcinoma completed the EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires. Problems with eating, reflux and nausea and vomiting were chosen as the primary HR-QoL endpoints. The secondary endpoints were the remaining HR-QoL domains, postoperative complications and pathology results. Multivariable linear regression was applied taking confounders age, gender, ASA classification and neoadjuvant therapy into account. Results 30 patients after gastrectomy and 71 after Ivor Lewis esophagectomy with a mean age of 63 years were included. Median follow-up was two years (range 12-84 months). Patients after total gastrectomy reported significantly less choking when swallowing and coughing (β=-5.952, 95% CI -9.437 – -2.466; β=-13.084, 95% CI -18.525 – -7.643). Problems with eating, reflux and nausea and vomiting were not significantly different between the two groups. No significant difference was found in postoperative complications or Clavien-Dindo grade. Significantly more lymph nodes were resected in esophagectomy group (p=0.008). No difference in number of positive lymph nodes or R0 resection was found. Conclusion After a follow-up of > 1 year choking when swallowing and coughing were less common after total gastrectomy. No significant difference was found in problems with eating, reflux or nausea and vomiting nor in postoperative complications or radicality of surgery. Based on this study no general preference can be given to either of the procedures for GEJ cancer. Patients may be informed about the HR-QoL domains that are likely to be affected by the different surgical procedures, which in turn may support shared decision making when a choice between the two treatment options is possible.

Effect of Pyloroplasty on Gastric Conduit Emptying and Patients' Quality of Life After Ivor Lewis Esophagectomy

2020 ◽  
Author(s):  
Carlo Alberto De Pasqual ◽  
Jacopo Weindelmayer ◽  
Laura Gobbi ◽  
Luca Alberti ◽  
Alessandro Veltri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Conduit ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy

scholarly journals Long-term health-related quality of life after McKeown and Ivor Lewis esophagectomy for esophageal carcinoma

2020 ◽  
Vol 33 (11) ◽  
Author(s):  
E Jezerskyte ◽  
L M Saadeh ◽  
E R C Hagens ◽  
M A G Sprangers ◽  
L Noteboom ◽  
...  
Keyword(s):  
Health Related Quality ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Related Quality ◽  
Health Related ◽  
Eortc Qlq ◽  
Mckeown Esophagectomy ◽  
Disease Free

Summary Introduction Both cervical (McKeown) and intrathoracic (Ivor Lewis) anastomosis of transthoracic esophagectomy are surgical procedures that can be performed for distal esophageal or gastro-esophageal junction (GEJ) cancer. The purpose of this study was to investigate the long-term health-related quality of life (HR-QoL) after McKeown and Ivor Lewis esophagectomy in a tertiary referral center. Methods Disease-free patients &gt;1 year following a McKeown or an Ivor Lewis esophagectomy with a two-field lymphadenectomy for a distal or GEJ carcinoma visiting the outpatient clinic between 2014 and 2018 were asked to complete the EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires. HR-QoL was investigated in both groups. Results A total of 89 patients were included after McKeown and 115 after Ivor Lewis esophagectomy. Median follow-up was 2.4 years (IQR 1.7–3.6). Patients after McKeown esophagectomy reported more problems with ‘eating with others’ compared to patients after Ivor Lewis esophagectomy (mean scores: 49.9 vs. 38.8). This difference was both clinically relevant and significant after correction for multiple testing (β = 11.1, 95% CI 3.105–19.127, P = 0.042). Patients in both groups reported a poorer HR-QoL (≥10 points) than the general population with respect to nausea and vomiting, dyspnea, appetite loss, financial difficulties, problems with eating, reflux, eating with others, choked when swallowing, trouble with coughing, and weight loss. Conclusion Long-term HR-QoL of disease-free patients following a McKeown or Ivor Lewis esophagectomy for a distal or GEJ carcinoma is largely comparable. Irrespective of the surgical technique, patients’ HR-QoL following esophagectomy is compromised. When given the choice, patients should be informed that after a McKeown esophagectomy more problems while eating with others can occur.

scholarly journals Gastric conduit perforation after Ivor Lewis esophagectomy successfully treated with endoscopic vacuum therapy (E-VAC): a case report

2020 ◽  
Vol 2020 (8) ◽  
Author(s):  
Selma Hetoja ◽  
Carlo Alberto De Pasqual ◽  
Valentina Mengardo ◽  
Jacopo Weindelmayer ◽  
Simone Giacopuzzi
Keyword(s):  
Gastric Conduit ◽  
Vacuum Therapy ◽  
Intestinal Surgery ◽  
Promising Technique ◽  
Ivor Lewis ◽  
Surgical Closure ◽  
Ivor Lewis Esophagectomy ◽  
First Case ◽  
Life Threatening ◽  
Endoscopic Vacuum Therapy

Abstract Gastric conduit perforation is a life-threatening complication after esophagectomy and currently there is no consensus about its optimal management. Endoscopic vacuum therapy (E-VAC) is a promising technique for the treatment of leaks and perforations after upper gastro-intestinal surgery. We report the case of a 65 years-old male patient who underwent an Ivor Lewis esophagectomy for esophago-gastric junction adenocarcinoma. He referred to our Emergency Department for septic shock and right hydropneumothorax. We performed an emergency thoracoscopy with intraoperative esophagogastroduodenoscopy which showed a pre-pyloric perforation of the gastric conduit. The perforation was initially treated with unsuccessful primary surgical closure and subsequently by means of E-VAC, firstly placed intraluminal and then intracavitary. With the latter technique, we assisted to a progressive clinical improvement until the definitive healing of the perforation. To our knowledge, this is the first case of a gastric tube perforation after esophagectomy successfully treated with E-VAC.

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