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

NCT05561907 | Recruiting DMC

• 1 other identifier: 21-1130
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Gastric Outlet Obstruction

Keywords

Gastric outlet obstruction; GOO; Periampullary malignancy; Periampullary cancer; Surgical gastrojejunostomy; Endoscopic gastrojejunostomy; Gastrojejunostomy; Enteral anastamosis

Outcome Measures

Primary Outcomes (1)

• Time to initiation of solid oral intake without symptoms of GOO

  Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2

  1 year

Secondary Outcomes (10)

• Safety of procedure

  1 year

• Technical success of procedure

  1 year

• Clinical success of procedure

  1 year

• Time to discharge

  1 year

• Change in BMI

  3 months

Study Arms (2)

Surgical gastrojejunostomy (SGJ)

ACTIVE COMPARATOR

An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.

Procedure: Surgical gastrojejunostomy (SGJ)

Endoscopic gastrojejunostomy (EGJ)

EXPERIMENTAL

A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.

Procedure: Endoscopic gastrojejunostomy (EGJ)

Interventions

Surgical gastrojejunostomy (SGJ) PROCEDURE

Laparoscopic gastrojejunostomy

Surgical gastrojejunostomy (SGJ)

Endoscopic gastrojejunostomy (EGJ) PROCEDURE

Endoscopic ultrasound (EUS) guided gastrojejunostomy

Endoscopic gastrojejunostomy (EGJ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (3)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Related Publications (26)

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  PMID: 31032096 BACKGROUND

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  PMID: 32390697 BACKGROUND

• 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.

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• 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.

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• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• Khashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26.

  PMID: 26215646 BACKGROUND

• Khashab MA, Tieu AH, Azola A, Ngamruengphong S, El Zein MH, Kumbhari V. EUS-guided gastrojejunostomy for management of complete gastric outlet obstruction. Gastrointest Endosc. 2015 Oct;82(4):745. doi: 10.1016/j.gie.2015.05.017. Epub 2015 Jun 16. No abstract available.

  PMID: 26092615 BACKGROUND

• Carbajo AY, Kahaleh M, Tyberg A. Clinical Review of EUS-guided Gastroenterostomy (EUS-GE). J Clin Gastroenterol. 2020 Jan;54(1):1-7. doi: 10.1097/MCG.0000000000001262.

  PMID: 31567785 BACKGROUND

• Barthet M, Binmoeller KF, Vanbiervliet G, Gonzalez JM, Baron TH, Berdah S. Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos). Gastrointest Endosc. 2015 Jan;81(1):215-8. doi: 10.1016/j.gie.2014.09.039.

  PMID: 25527056 BACKGROUND

• Ge PS, Young JY, Dong W, Thompson CC. EUS-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction. Surg Endosc. 2019 Oct;33(10):3404-3411. doi: 10.1007/s00464-018-06636-3. Epub 2019 Feb 6.

  PMID: 30725254 BACKGROUND

• Kerdsirichairat T, Irani S, Yang J, Brewer Gutierrez OI, Moran R, Sanaei O, Dbouk M, Kumbhari V, Singh VK, Kalloo AN, Khashab MA. Durability and long-term outcomes of direct EUS-guided gastroenterostomy using lumen-apposing metal stents for gastric outlet obstruction. Endosc Int Open. 2019 Feb;7(2):E144-E150. doi: 10.1055/a-0799-9939. Epub 2019 Jan 30.

  PMID: 30705945 BACKGROUND

• James TW, Greenberg S, Grimm IS, Baron TH. EUS-guided gastroenteric anastomosis as a bridge to definitive treatment in benign gastric outlet obstruction. Gastrointest Endosc. 2020 Mar;91(3):537-542. doi: 10.1016/j.gie.2019.11.017. Epub 2019 Nov 20.

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  PMID: 26282674 BACKGROUND

• Tyberg A, Perez-Miranda M, Sanchez-Ocana R, Penas I, de la Serna C, Shah J, Binmoeller K, Gaidhane M, Grimm I, Baron T, Kahaleh M. Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Endosc Int Open. 2016 Mar;4(3):E276-81. doi: 10.1055/s-0042-101789.

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• Perez-Miranda M, Tyberg A, Poletto D, Toscano E, Gaidhane M, Desai AP, Kumta NA, Fayad L, Nieto J, Barthet M, Shah R, Brauer BC, Sharaiha RZ, Kahaleh M. EUS-guided Gastrojejunostomy Versus Laparoscopic Gastrojejunostomy: An International Collaborative Study. J Clin Gastroenterol. 2017 Nov/Dec;51(10):896-899. doi: 10.1097/MCG.0000000000000887.

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MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Petros Benias, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Arvind Trindade, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Stewart

CONTACT

718-470-4667; mstewart8@northwell.edu

Hye Jeong Jang

CONTACT

718-470-7983; hjang3@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopic Surgery

Model Details: Subjects will be randomly assigned in a 1:1 ratio to surgical gastrojejunostomy (SGJ) or endoscopic gastrojejunostomy (EGJ).

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 30, 2022
• Study Start: October 28, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)