Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Обзор

Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment

Подробное описание

After potential subjects are screened from the physicians' schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study.

After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner.

On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status.

Data will be collected during and immediately following the procedure to assess for any possible adverse events.

Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure.

QOL Scoring Systems GOOSS- Gastric Outlet Obstruction Symptom Score

* 1 Inadequate or no oral intake * 2 Liquids/thickened liquids * 3 Semisolids/ low residue * 4 unmodified

GFS- Gut Function Score from Lowe et al 2002

* 0 Profuse vomiting * 1 Nausea and occasional vomiting * 2 Nausea only * 3 Normal gut function

Pre-Procedure Variables to Record Demographic

* Gender * Weight * BMI * Cancer Type

Clinical Parameters

* GOOSS * Gut Function Score * Karnofsky Performance Scale

Procedural Parameters

* EUS-GJ: presence of ascites, able to pass scope beyond obstruction, use of wire to stabilize position, Length of procedure, intraprocedural AEs, Stent size used, successful completion of procedure * Laparoscopic GJ: presence of ascites, length of procedure, intraprocedural AEs, conversion to open GJ, successful completion of procedure

Post-procedure Hospitalization Daily Function

* GOOSS * Gut Function Score * Time to initiation of oral intake liquids * Time to initiation of oral intake solids * Time to discharge * Post procedural AEs

30 Day Outcomes * GOOSS * Gut Function Score * Karnofsky Performance Scale * Weight/BMI * Able to tolerate TB approved chemotherapeutic regimen

Вмешательства

• Процедура Surgical gastrojejunostomy (SGJ)
  Laparoscopic gastrojejunostomy
• Процедура Endoscopic gastrojejunostomy (EGJ)
  Endoscopic ultrasound (EUS) guided gastrojejunostomy

Первичные конечные точки

• Time to initiation of solid oral intake without symptoms of GOO [Срок оценки: 1 year]

Вторичные конечные точки (10)

• Safety of procedure [Срок оценки: 1 year]
• Technical success of procedure [Срок оценки: 1 year]
• Clinical success of procedure [Срок оценки: 1 year]
• Time to discharge [Срок оценки: 1 year]
• Change in BMI [Срок оценки: 3 months]
• Change in albumin levels [Срок оценки: 3 months]
• Change in Gastric Outlet Obstruction Symptom Score (GOOSS) [Срок оценки: 1 year]
• Change in Gut Function Score (GFS) [Срок оценки: 1 year]
• Karnofsky Performance Scale (KPS) [Срок оценки: 30 Days]
• Chemotherapeutic regimen tolerance [Срок оценки: 30 Days]

Критерии участия

Критерии включения

• Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
• Symptoms of gastric outlet obstruction (at least 2 of 4 required):

• post prandial vomiting,
• abdominal pain,
• inability to tolerate PO,
• imaging consistent with GOO
• Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
• Age >18 years old
• Life expectancy greater than 2 months or failed duodenal stenting
• Surgical Candidate/Tolerate General Anesthesia
• Unresectable or metastatic disease

Критерии исключения

• Age< 18 years old
• Pregnancy
• Intestinal obstruction distal to the Ligament of Treitz
• Evidence of other luminal strictures of the GI tract
• Previous gastric or periampullary surgery
• Inability to complete quality of life surveys (QOLS)
• Presence of abdominal ascites

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Robert Wood Johnson University Hospital — New Brunswick
• North Shore University Hospital — Manhasset
• Long Island Jewish Medical Center — New Hyde Park
• Lenox Hill Hospital — New York

Публикации

• Lorusso D, Giliberti A, Bianco M, Lantone G, Leandro G. Stomach-partitioning gastrojejunostomy is better than conventional gastrojejunostomy in palliative care of gastric outlet obstruction for gastric or pancreatic cancer: a meta-analysis. J Gastrointest Oncol. 2019 Apr;10(2):283-291. doi: 10.21037/jgo.2018.10.10. PMID 31032096
• Troncone E, Fugazza A, Cappello A, Del Vecchio Blanco G, Monteleone G, Repici A, Teoh AYB, Anderloni A. Malignant gastric outlet obstruction: Which is the best therapeutic option? World J Gastroenterol. 2020 Apr 28;26(16):1847-1860. doi: 10.3748/wjg.v26.i16.1847. PMID 32390697
• Maetani I, Inoue H, Sato M, Ohashi S, Igarashi Y, Sakai Y. Peroral insertion techniques of self-expanding metal stents for malignant gastric outlet and duodenal stenoses. Gastrointest Endosc. 1996 Oct;44(4):468-71. doi: 10.1016/s0016-5107(96)70102-5. PMID 8905371
• Tonozuka R, Tsuchiya T, Mukai S, Nagakawa Y, Itoi T. Endoscopic Ultrasonography-Guided Gastroenterostomy Techniques for Treatment of Malignant Gastric Outlet Obstruction. Clin Endosc. 2020 Sep;53(5):510-518. doi: 10.5946/ce.2020.151. Epub 2020 Sep 23. PMID 32962331
• Khashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9. PMID 23299137
• Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, Kuipers EJ, Siersema PD; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial. Gastrointest Endosc. 2010 Mar;71(3):490-9. doi: 10.1016/j.gie.2009.09.042. Epub 2009 Dec 8. PMID 20003966
• Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96. doi: 10.1002/jso.20828. PMID 17474082
• Itoi T, Itokawa F, Uraoka T, Gotoda T, Horii J, Goto O, Moriyasu F, Moon JH, Kitagawa Y, Yahagi N. Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent (with videos). Gastrointest Endosc. 2013 Dec;78(6):934-939. doi: 10.1016/j.gie.2013.09.025. PMID 24237949

Идентификаторы

NCT: NCT05561907 · 21-1130

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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