784. NO SUPPORT FOR IMMEDIATE POSTOPERATIVE REMOVAL OF NASOGASTRIC TUBE AFTER ESOPHAGECTOMY, RESULTS FROM A NORDIC MULTICENTER RANDOMIZED CONTROLLED TRIAL
Abstract Background Esophagectomy is central in curative treatment of esophageal and gastroesophageal junctional cancer. Postoperative nasogastric (NG) tube for drainage of the gastric conduit is routine in most centers. The NG tube is typically associated with significant discomfort for the patient...
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| Veröffentlicht in: | Diseases of the esophagus 2024-09, Vol.37 (Supplement_1) |
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| creator | Hedberg, Jakob Kauppila, Joonas Aahlin, Eirik Kjus Edholm, David Johnsen, Gjermund Johansson, Jan Lagergren, Pernilla Lindblad, Mats Lindberg, Fredrik Helminen, Olli Löfdahl, Per Førland, Dag Tidemann Vikhammer, Mads Svendsen, Lars Bo Sundbom, Magnus Szabo, Eva Åkesson, Oscar Nilsson, Magnus Achiam, Michael Mala, Tom |
| description | Abstract
Background
Esophagectomy is central in curative treatment of esophageal and gastroesophageal junctional cancer. Postoperative nasogastric (NG) tube for drainage of the gastric conduit is routine in most centers. The NG tube is typically associated with significant discomfort for the patients and may have risks of its own. Immediate postoperative removal of the NG tube has been suggested and deemed safe in several smaller trials. We hypothesized that immediate postoperative removal of the NG tube is non-inferior to keeping the NG-tube in place for 5 days postoperatively, with regard to anastomotic leak and other early outcomes.
Methods
Esophagectomy patients with a gastric conduit reconstruction were included in a multicenter, randomized controlled trial between February 2022 and March 2024. A 1:1 randomization stratified for center, age and anastomotic site (thorax/neck) was performed between immediate postoperative removal of NG tube (intervention) and 5 days of NG tube use (control). All patients underwent chest CT postoperative day 7. Anastomotic leak was the primary endpoint and a non-inferiority threshold of -9% difference in proportion of anastomotic leak, including 95% confidence interval, was set. Secondary endpoints included overall complications, pneumonia, length of stay as well as days in high dependency ward.
Results
Intention to treat analyses were performed on 444 patients whereof 215 were randomized to immediate NG-tube removal and 229 to control. Mean age was 67 years and neck anastomosis was performed in 78 patients (18%). 47 patients (22 %) had leak in the no NG tube group compared to 35 (15%) in the control group. Non-inferiority could not be established with a difference leak proportion to the advantage of NG tube use of 6.6% (95% CI: 13.8%-(-0.7%)). Overall complications (Clavien-Dindo >2) occurred in 94 patients (44%) in the experimental group and 91 patients (40%) in the control group. Overall 30d mortality was 1.1%.
Conclusion
In this randomized controlled multicenter trial, the by far largest to be performed so far, we could not establish non-inferiority for abstaining from postoperative NG tube use after esophagectomy with regards to anastomotic leak, and therefore support NG tube use. The somewhat high proportion of leak could be partly due to meticulous complication registration, including CT with peroral contrast on day seven in all patients. Use of postoperative decompression of the gastric conduit with an NG tube sh |
| doi_str_mv | 10.1093/dote/doae057.380 |
| format | Article |
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Background
Esophagectomy is central in curative treatment of esophageal and gastroesophageal junctional cancer. Postoperative nasogastric (NG) tube for drainage of the gastric conduit is routine in most centers. The NG tube is typically associated with significant discomfort for the patients and may have risks of its own. Immediate postoperative removal of the NG tube has been suggested and deemed safe in several smaller trials. We hypothesized that immediate postoperative removal of the NG tube is non-inferior to keeping the NG-tube in place for 5 days postoperatively, with regard to anastomotic leak and other early outcomes.
Methods
Esophagectomy patients with a gastric conduit reconstruction were included in a multicenter, randomized controlled trial between February 2022 and March 2024. A 1:1 randomization stratified for center, age and anastomotic site (thorax/neck) was performed between immediate postoperative removal of NG tube (intervention) and 5 days of NG tube use (control). All patients underwent chest CT postoperative day 7. Anastomotic leak was the primary endpoint and a non-inferiority threshold of -9% difference in proportion of anastomotic leak, including 95% confidence interval, was set. Secondary endpoints included overall complications, pneumonia, length of stay as well as days in high dependency ward.
Results
Intention to treat analyses were performed on 444 patients whereof 215 were randomized to immediate NG-tube removal and 229 to control. Mean age was 67 years and neck anastomosis was performed in 78 patients (18%). 47 patients (22 %) had leak in the no NG tube group compared to 35 (15%) in the control group. Non-inferiority could not be established with a difference leak proportion to the advantage of NG tube use of 6.6% (95% CI: 13.8%-(-0.7%)). Overall complications (Clavien-Dindo >2) occurred in 94 patients (44%) in the experimental group and 91 patients (40%) in the control group. Overall 30d mortality was 1.1%.
Conclusion
In this randomized controlled multicenter trial, the by far largest to be performed so far, we could not establish non-inferiority for abstaining from postoperative NG tube use after esophagectomy with regards to anastomotic leak, and therefore support NG tube use. The somewhat high proportion of leak could be partly due to meticulous complication registration, including CT with peroral contrast on day seven in all patients. Use of postoperative decompression of the gastric conduit with an NG tube should be encouraged.</description><identifier>ISSN: 1120-8694</identifier><identifier>EISSN: 1442-2050</identifier><identifier>DOI: 10.1093/dote/doae057.380</identifier><language>eng</language><publisher>Oxford University Press</publisher><ispartof>Diseases of the esophagus, 2024-09, Vol.37 (Supplement_1)</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Hedberg, Jakob</creatorcontrib><creatorcontrib>Kauppila, Joonas</creatorcontrib><creatorcontrib>Aahlin, Eirik Kjus</creatorcontrib><creatorcontrib>Edholm, David</creatorcontrib><creatorcontrib>Johnsen, Gjermund</creatorcontrib><creatorcontrib>Johansson, Jan</creatorcontrib><creatorcontrib>Lagergren, Pernilla</creatorcontrib><creatorcontrib>Lindblad, Mats</creatorcontrib><creatorcontrib>Lindberg, Fredrik</creatorcontrib><creatorcontrib>Helminen, Olli</creatorcontrib><creatorcontrib>Löfdahl, Per</creatorcontrib><creatorcontrib>Førland, Dag Tidemann</creatorcontrib><creatorcontrib>Vikhammer, Mads</creatorcontrib><creatorcontrib>Svendsen, Lars Bo</creatorcontrib><creatorcontrib>Sundbom, Magnus</creatorcontrib><creatorcontrib>Szabo, Eva</creatorcontrib><creatorcontrib>Åkesson, Oscar</creatorcontrib><creatorcontrib>Nilsson, Magnus</creatorcontrib><creatorcontrib>Achiam, Michael</creatorcontrib><creatorcontrib>Mala, Tom</creatorcontrib><title>784. NO SUPPORT FOR IMMEDIATE POSTOPERATIVE REMOVAL OF NASOGASTRIC TUBE AFTER ESOPHAGECTOMY, RESULTS FROM A NORDIC MULTICENTER RANDOMIZED CONTROLLED TRIAL</title><title>Diseases of the esophagus</title><description>Abstract
Background
Esophagectomy is central in curative treatment of esophageal and gastroesophageal junctional cancer. Postoperative nasogastric (NG) tube for drainage of the gastric conduit is routine in most centers. The NG tube is typically associated with significant discomfort for the patients and may have risks of its own. Immediate postoperative removal of the NG tube has been suggested and deemed safe in several smaller trials. We hypothesized that immediate postoperative removal of the NG tube is non-inferior to keeping the NG-tube in place for 5 days postoperatively, with regard to anastomotic leak and other early outcomes.
Methods
Esophagectomy patients with a gastric conduit reconstruction were included in a multicenter, randomized controlled trial between February 2022 and March 2024. A 1:1 randomization stratified for center, age and anastomotic site (thorax/neck) was performed between immediate postoperative removal of NG tube (intervention) and 5 days of NG tube use (control). All patients underwent chest CT postoperative day 7. Anastomotic leak was the primary endpoint and a non-inferiority threshold of -9% difference in proportion of anastomotic leak, including 95% confidence interval, was set. Secondary endpoints included overall complications, pneumonia, length of stay as well as days in high dependency ward.
Results
Intention to treat analyses were performed on 444 patients whereof 215 were randomized to immediate NG-tube removal and 229 to control. Mean age was 67 years and neck anastomosis was performed in 78 patients (18%). 47 patients (22 %) had leak in the no NG tube group compared to 35 (15%) in the control group. Non-inferiority could not be established with a difference leak proportion to the advantage of NG tube use of 6.6% (95% CI: 13.8%-(-0.7%)). Overall complications (Clavien-Dindo >2) occurred in 94 patients (44%) in the experimental group and 91 patients (40%) in the control group. Overall 30d mortality was 1.1%.
Conclusion
In this randomized controlled multicenter trial, the by far largest to be performed so far, we could not establish non-inferiority for abstaining from postoperative NG tube use after esophagectomy with regards to anastomotic leak, and therefore support NG tube use. The somewhat high proportion of leak could be partly due to meticulous complication registration, including CT with peroral contrast on day seven in all patients. Use of postoperative decompression of the gastric conduit with an NG tube should be encouraged.</description><issn>1120-8694</issn><issn>1442-2050</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNqFkM1OwzAQhCMEEqVw5-g7pKzt_B5N4rSRkjhy3EpwiZzEkUCgVgkceBWeFlftncvuaDUzK32Oc49hhSGmT8P-y9ihDfjhikZw4Syw5xGXgA-XVmMCbhTE3rVzM8_vADikQbRwfsPIW6FKoGZb10IqlAmJ8rLkac4UR7VolKi5ZCrfcSR5KXasQCJDFWvEmjVK5glS22eOWKa4RLwR9YateaJE-fJoA822UA3KpCgRs29kav2lveUJr44ByapUlPkrT1EiKiVFUVhpa1lx61yN-mM2d-e9dFTGVbJxC7HOE1a4PcYxuH6Aw3AcRj10tAPidTBGvSaa9Ab3Ro9DHICnjaZkxJTgKI4h1ND5Y9cZ2mG6dOBU20_7eZ7M2B6mt089_bQY2iPa9oi2PaNtLVobeThF9t-H_91_NJJyZA</recordid><startdate>20240901</startdate><enddate>20240901</enddate><creator>Hedberg, Jakob</creator><creator>Kauppila, Joonas</creator><creator>Aahlin, Eirik Kjus</creator><creator>Edholm, David</creator><creator>Johnsen, Gjermund</creator><creator>Johansson, Jan</creator><creator>Lagergren, Pernilla</creator><creator>Lindblad, Mats</creator><creator>Lindberg, Fredrik</creator><creator>Helminen, Olli</creator><creator>Löfdahl, Per</creator><creator>Førland, Dag Tidemann</creator><creator>Vikhammer, Mads</creator><creator>Svendsen, Lars Bo</creator><creator>Sundbom, Magnus</creator><creator>Szabo, Eva</creator><creator>Åkesson, Oscar</creator><creator>Nilsson, Magnus</creator><creator>Achiam, Michael</creator><creator>Mala, Tom</creator><general>Oxford University Press</general><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20240901</creationdate><title>784. NO SUPPORT FOR IMMEDIATE POSTOPERATIVE REMOVAL OF NASOGASTRIC TUBE AFTER ESOPHAGECTOMY, RESULTS FROM A NORDIC MULTICENTER RANDOMIZED CONTROLLED TRIAL</title><author>Hedberg, Jakob ; Kauppila, Joonas ; Aahlin, Eirik Kjus ; Edholm, David ; Johnsen, Gjermund ; Johansson, Jan ; Lagergren, Pernilla ; Lindblad, Mats ; Lindberg, Fredrik ; Helminen, Olli ; Löfdahl, Per ; Førland, Dag Tidemann ; Vikhammer, Mads ; Svendsen, Lars Bo ; Sundbom, Magnus ; Szabo, Eva ; Åkesson, Oscar ; Nilsson, Magnus ; Achiam, Michael ; Mala, Tom</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1190-56177fdfadb3b024b0f8ca2a2ce1ceafd9604aea32f132189907a0b5fbbe3b13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hedberg, Jakob</creatorcontrib><creatorcontrib>Kauppila, Joonas</creatorcontrib><creatorcontrib>Aahlin, Eirik Kjus</creatorcontrib><creatorcontrib>Edholm, David</creatorcontrib><creatorcontrib>Johnsen, Gjermund</creatorcontrib><creatorcontrib>Johansson, Jan</creatorcontrib><creatorcontrib>Lagergren, Pernilla</creatorcontrib><creatorcontrib>Lindblad, Mats</creatorcontrib><creatorcontrib>Lindberg, Fredrik</creatorcontrib><creatorcontrib>Helminen, Olli</creatorcontrib><creatorcontrib>Löfdahl, Per</creatorcontrib><creatorcontrib>Førland, Dag Tidemann</creatorcontrib><creatorcontrib>Vikhammer, Mads</creatorcontrib><creatorcontrib>Svendsen, Lars Bo</creatorcontrib><creatorcontrib>Sundbom, Magnus</creatorcontrib><creatorcontrib>Szabo, Eva</creatorcontrib><creatorcontrib>Åkesson, Oscar</creatorcontrib><creatorcontrib>Nilsson, Magnus</creatorcontrib><creatorcontrib>Achiam, Michael</creatorcontrib><creatorcontrib>Mala, Tom</creatorcontrib><collection>CrossRef</collection><jtitle>Diseases of the esophagus</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hedberg, Jakob</au><au>Kauppila, Joonas</au><au>Aahlin, Eirik Kjus</au><au>Edholm, David</au><au>Johnsen, Gjermund</au><au>Johansson, Jan</au><au>Lagergren, Pernilla</au><au>Lindblad, Mats</au><au>Lindberg, Fredrik</au><au>Helminen, Olli</au><au>Löfdahl, Per</au><au>Førland, Dag Tidemann</au><au>Vikhammer, Mads</au><au>Svendsen, Lars Bo</au><au>Sundbom, Magnus</au><au>Szabo, Eva</au><au>Åkesson, Oscar</au><au>Nilsson, Magnus</au><au>Achiam, Michael</au><au>Mala, Tom</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>784. NO SUPPORT FOR IMMEDIATE POSTOPERATIVE REMOVAL OF NASOGASTRIC TUBE AFTER ESOPHAGECTOMY, RESULTS FROM A NORDIC MULTICENTER RANDOMIZED CONTROLLED TRIAL</atitle><jtitle>Diseases of the esophagus</jtitle><date>2024-09-01</date><risdate>2024</risdate><volume>37</volume><issue>Supplement_1</issue><issn>1120-8694</issn><eissn>1442-2050</eissn><abstract>Abstract
Background
Esophagectomy is central in curative treatment of esophageal and gastroesophageal junctional cancer. Postoperative nasogastric (NG) tube for drainage of the gastric conduit is routine in most centers. The NG tube is typically associated with significant discomfort for the patients and may have risks of its own. Immediate postoperative removal of the NG tube has been suggested and deemed safe in several smaller trials. We hypothesized that immediate postoperative removal of the NG tube is non-inferior to keeping the NG-tube in place for 5 days postoperatively, with regard to anastomotic leak and other early outcomes.
Methods
Esophagectomy patients with a gastric conduit reconstruction were included in a multicenter, randomized controlled trial between February 2022 and March 2024. A 1:1 randomization stratified for center, age and anastomotic site (thorax/neck) was performed between immediate postoperative removal of NG tube (intervention) and 5 days of NG tube use (control). All patients underwent chest CT postoperative day 7. Anastomotic leak was the primary endpoint and a non-inferiority threshold of -9% difference in proportion of anastomotic leak, including 95% confidence interval, was set. Secondary endpoints included overall complications, pneumonia, length of stay as well as days in high dependency ward.
Results
Intention to treat analyses were performed on 444 patients whereof 215 were randomized to immediate NG-tube removal and 229 to control. Mean age was 67 years and neck anastomosis was performed in 78 patients (18%). 47 patients (22 %) had leak in the no NG tube group compared to 35 (15%) in the control group. Non-inferiority could not be established with a difference leak proportion to the advantage of NG tube use of 6.6% (95% CI: 13.8%-(-0.7%)). Overall complications (Clavien-Dindo >2) occurred in 94 patients (44%) in the experimental group and 91 patients (40%) in the control group. Overall 30d mortality was 1.1%.
Conclusion
In this randomized controlled multicenter trial, the by far largest to be performed so far, we could not establish non-inferiority for abstaining from postoperative NG tube use after esophagectomy with regards to anastomotic leak, and therefore support NG tube use. The somewhat high proportion of leak could be partly due to meticulous complication registration, including CT with peroral contrast on day seven in all patients. Use of postoperative decompression of the gastric conduit with an NG tube should be encouraged.</abstract><pub>Oxford University Press</pub><doi>10.1093/dote/doae057.380</doi><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current) |
| title | 784. NO SUPPORT FOR IMMEDIATE POSTOPERATIVE REMOVAL OF NASOGASTRIC TUBE AFTER ESOPHAGECTOMY, RESULTS FROM A NORDIC MULTICENTER RANDOMIZED CONTROLLED TRIAL |
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