Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial
Abstract Background Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment for patients with a reasonable life expectancy and adequate performance...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-09-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07522-7 |
| _version_ | 1827708498160386048 |
|---|---|
| author | Janine B. Kastelijn Yorick L. van de Pavert Marc G. Besselink Paul Fockens Rogier P. Voermans Roy L. J. van Wanrooij Thomas R. de Wijkerslooth Wouter L. Curvers Ignace H. J. T. de Hingh Marco J. Bruno Bas Groot Koerkamp Gijs A. Patijn Alexander C. Poen Jeanin E. van Hooft Akin Inderson J. Sven D. Mieog Jan-Werner Poley Alderina Bijlsma Daan J. Lips Niels G. Venneman Robert C. Verdonk Hendrik M. van Dullemen Frederik J. H. Hoogwater Geert W. J. Frederix I. Quintus Molenaar Paco M. J. Welsing Leon M. G. Moons Hjalmar C. van Santvoort Frank P. Vleggaar for the Dutch Pancreatic Cancer Group |
| author_facet | Janine B. Kastelijn Yorick L. van de Pavert Marc G. Besselink Paul Fockens Rogier P. Voermans Roy L. J. van Wanrooij Thomas R. de Wijkerslooth Wouter L. Curvers Ignace H. J. T. de Hingh Marco J. Bruno Bas Groot Koerkamp Gijs A. Patijn Alexander C. Poen Jeanin E. van Hooft Akin Inderson J. Sven D. Mieog Jan-Werner Poley Alderina Bijlsma Daan J. Lips Niels G. Venneman Robert C. Verdonk Hendrik M. van Dullemen Frederik J. H. Hoogwater Geert W. J. Frederix I. Quintus Molenaar Paco M. J. Welsing Leon M. G. Moons Hjalmar C. van Santvoort Frank P. Vleggaar for the Dutch Pancreatic Cancer Group |
| author_sort | Janine B. Kastelijn |
| collection | DOAJ |
| description | Abstract Background Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment for patients with a reasonable life expectancy and adequate performance status is a laparoscopic surgical gastrojejunostomy (SGJ). Recently, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) emerged as a promising alternative to the surgical approach. The present study aims to compare these treatment modalities in terms of efficacy, safety, and costs. Methods The ENDURO-study is a multicentre, open-label, parallel-group randomized controlled trial. In total, ninety-six patients with gastric outlet obstruction caused by an irresectable or metastasized malignancy will be 1:1 randomized to either SGJ or EUS-GE. The primary endpoint is time to tolerate at least soft solids. The co-primary endpoint is the proportion of patients with persisting or recurring symptoms of gastric outlet obstruction for which a reintervention is required. Secondary endpoints are technical and clinical success, quality of life, gastroenterostomy dysfunction, reinterventions, time to reintervention, adverse events, quality of life, time to start chemotherapy, length of hospital stay, readmissions, weight, survival, and costs. Discussion The ENDURO-study assesses whether EUS-GE, as compared to SGJ, results in a faster resumption of solid oral intake and is non-inferior regarding reinterventions for persistent or recurrent obstructive symptoms in patients with malignant GOO. This trial aims to guide future treatment strategies and to improve quality of life in a palliative setting. Trial registration International Clinical Trials Registry Platform (ICTRP): NL9592. Registered on 07 July 2021. |
| first_indexed | 2024-03-10T17:05:26Z |
| format | Article |
| id | doaj.art-001c3b56a6ab44448598c74796655bbf |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:05:26Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-001c3b56a6ab44448598c74796655bbf2023-11-20T10:49:34ZengBMCTrials1745-62152023-09-0124111410.1186/s13063-023-07522-7Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trialJanine B. Kastelijn0Yorick L. van de Pavert1Marc G. Besselink2Paul Fockens3Rogier P. Voermans4Roy L. J. van Wanrooij5Thomas R. de Wijkerslooth6Wouter L. Curvers7Ignace H. J. T. de Hingh8Marco J. Bruno9Bas Groot Koerkamp10Gijs A. Patijn11Alexander C. Poen12Jeanin E. van Hooft13Akin Inderson14J. Sven D. Mieog15Jan-Werner Poley16Alderina Bijlsma17Daan J. Lips18Niels G. Venneman19Robert C. Verdonk20Hendrik M. van Dullemen21Frederik J. H. Hoogwater22Geert W. J. Frederix23I. Quintus Molenaar24Paco M. J. Welsing25Leon M. G. Moons26Hjalmar C. van Santvoort27Frank P. Vleggaar28for the Dutch Pancreatic Cancer GroupDepartment of Gastroenterology and Hepatology, University Medical Center UtrechtDepartment of Gastroenterology and Hepatology, University Medical Center UtrechtDepartment of Surgery, Amsterdam UMC, Location University of AmsterdamCancer Center AmsterdamCancer Center AmsterdamCancer Center AmsterdamDepartment of Gastrointestinal Oncology, Netherlands Cancer InstituteDepartment of Gastroenterology and Hepatology, Catharina HospitalDepartment of Surgery, Catharina HospitalDepartment of Gastroenterology and Hepatology, Erasmus University Medical CenterDepartment of Surgery, Erasmus University Medical Center Cancer InstituteDepartment of Surgery, Isala ClinicsDepartment of Gastroenterology and Hepatology, Isala ClinicsDepartment of Gastroenterology and Hepatology, Leiden University Medical CenterDepartment of Gastroenterology and Hepatology, Leiden University Medical CenterDepartment of Surgery, Leiden University Medical CenterDepartment of Gastroenterology and Hepatology, Maastricht University Medical Center+Department of Gastroenterology and Hepatology, Martini HospitalDepartment of Surgery, Medisch Spectrum TwenteDepartment of Gastroenterology and Hepatology, Medisch Spectrum TwenteDepartment of Gastroenterology and Hepatology, St. Antonius HospitalDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, University of GroningenDepartment of Surgery, University Medical Center Groningen, University of GroningenJulius Center for Health Sciences and Primary Care, University Medical Center UtrechtDepartment of Surgery, St. Antonius HospitalDivision of Internal Medicine and Dermatology, University Medical Center UtrechtDepartment of Gastroenterology and Hepatology, University Medical Center UtrechtDepartment of Surgery, St. Antonius HospitalDepartment of Gastroenterology and Hepatology, University Medical Center UtrechtAbstract Background Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment for patients with a reasonable life expectancy and adequate performance status is a laparoscopic surgical gastrojejunostomy (SGJ). Recently, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) emerged as a promising alternative to the surgical approach. The present study aims to compare these treatment modalities in terms of efficacy, safety, and costs. Methods The ENDURO-study is a multicentre, open-label, parallel-group randomized controlled trial. In total, ninety-six patients with gastric outlet obstruction caused by an irresectable or metastasized malignancy will be 1:1 randomized to either SGJ or EUS-GE. The primary endpoint is time to tolerate at least soft solids. The co-primary endpoint is the proportion of patients with persisting or recurring symptoms of gastric outlet obstruction for which a reintervention is required. Secondary endpoints are technical and clinical success, quality of life, gastroenterostomy dysfunction, reinterventions, time to reintervention, adverse events, quality of life, time to start chemotherapy, length of hospital stay, readmissions, weight, survival, and costs. Discussion The ENDURO-study assesses whether EUS-GE, as compared to SGJ, results in a faster resumption of solid oral intake and is non-inferior regarding reinterventions for persistent or recurrent obstructive symptoms in patients with malignant GOO. This trial aims to guide future treatment strategies and to improve quality of life in a palliative setting. Trial registration International Clinical Trials Registry Platform (ICTRP): NL9592. Registered on 07 July 2021.https://doi.org/10.1186/s13063-023-07522-7Gastric outlet obstructionMalignancyGastroenterostomyGastrojejunostomyEndoscopic ultrasonographySurgery |
| spellingShingle | Janine B. Kastelijn Yorick L. van de Pavert Marc G. Besselink Paul Fockens Rogier P. Voermans Roy L. J. van Wanrooij Thomas R. de Wijkerslooth Wouter L. Curvers Ignace H. J. T. de Hingh Marco J. Bruno Bas Groot Koerkamp Gijs A. Patijn Alexander C. Poen Jeanin E. van Hooft Akin Inderson J. Sven D. Mieog Jan-Werner Poley Alderina Bijlsma Daan J. Lips Niels G. Venneman Robert C. Verdonk Hendrik M. van Dullemen Frederik J. H. Hoogwater Geert W. J. Frederix I. Quintus Molenaar Paco M. J. Welsing Leon M. G. Moons Hjalmar C. van Santvoort Frank P. Vleggaar for the Dutch Pancreatic Cancer Group Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial Trials Gastric outlet obstruction Malignancy Gastroenterostomy Gastrojejunostomy Endoscopic ultrasonography Surgery |
| title | Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial |
| title_full | Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial |
| title_fullStr | Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial |
| title_full_unstemmed | Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial |
| title_short | Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial |
| title_sort | endoscopic ultrasonography guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction enduro study protocol for a randomized controlled trial |
| topic | Gastric outlet obstruction Malignancy Gastroenterostomy Gastrojejunostomy Endoscopic ultrasonography Surgery |
| url | https://doi.org/10.1186/s13063-023-07522-7 |
| work_keys_str_mv | AT janinebkastelijn endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT yoricklvandepavert endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT marcgbesselink endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT paulfockens endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT rogierpvoermans endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT royljvanwanrooij endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT thomasrdewijkerslooth endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT wouterlcurvers endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT ignacehjtdehingh endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT marcojbruno endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT basgrootkoerkamp endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT gijsapatijn endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT alexandercpoen endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT jeaninevanhooft endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT akininderson endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT jsvendmieog endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT janwernerpoley endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT alderinabijlsma endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT daanjlips endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT nielsgvenneman endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT robertcverdonk endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT hendrikmvandullemen endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT frederikjhhoogwater endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT geertwjfrederix endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT iquintusmolenaar endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT pacomjwelsing endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT leonmgmoons endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT hjalmarcvansantvoort endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT frankpvleggaar endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial AT forthedutchpancreaticcancergroup endoscopicultrasonographyguidedgastroenterostomyversussurgicalgastrojejunostomyforpalliationofmalignantgastricoutletobstructionendurostudyprotocolforarandomizedcontrolledtrial |