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

NCT ID: NCT05561907

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2025-06-30

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

Detailed Description

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

Conditions

Gastric Outlet Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical gastrojejunostomy (SGJ)

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

Group Type: ACTIVE_COMPARATOR

Surgical gastrojejunostomy (SGJ)

Intervention Type: PROCEDURE

Laparoscopic gastrojejunostomy

Endoscopic gastrojejunostomy (EGJ)

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

Group Type: EXPERIMENTAL

Endoscopic gastrojejunostomy (EGJ)

Intervention Type: PROCEDURE

Endoscopic ultrasound (EUS) guided gastrojejunostomy

Interventions

Surgical gastrojejunostomy (SGJ)

Laparoscopic gastrojejunostomy

Intervention Type: PROCEDURE

Endoscopic gastrojejunostomy (EGJ)

Endoscopic ultrasound (EUS) guided gastrojejunostomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer

2. Symptoms of gastric outlet obstruction (at least 2 of 4 required):

1. post prandial vomiting,

2. abdominal pain,

3. inability to tolerate PO,

4. imaging consistent with GOO

3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)

4. Age >18 years old

5. Life expectancy greater than 2 months or failed duodenal stenting

6. Surgical Candidate/Tolerate General Anesthesia

7. Unresectable or metastatic disease

Exclusion Criteria

1. Age< 18 years old

2. Pregnancy

3. Intestinal obstruction distal to the Ligament of Treitz

4. Evidence of other luminal strictures of the GI tract

5. Previous gastric or periampullary surgery

6. Inability to complete quality of life surveys (QOLS)

7. Presence of abdominal ascites

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Petros Benias

Director of Endoscopic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petros Benias, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Arvind Trindade, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

North Shore University Hospital

Manhasset, New York, United States

Site Status: RECRUITING

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status: RECRUITING

Lenox Hill Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Molly Stewart

Role: CONTACT

mstewart8@northwell.edu

718-470-4667

Hye Jeong Jang

Role: CONTACT

hjang3@northwell.edu

718-470-7983

Facility Contacts

Molly Stewart

Role: primary

mstewart8@northwell.edu

718-470-4667

Hye Jeong Jang

Role: backup

hjang3@northwell.edu

718-470-7983

Molly Stewart

Role: primary

mstewart8@northwell.edu

718-470-4667

Hye Jeong Jang

Role: backup

hjang3@northwell.edu

718-470-7983

Molly Stewart

Role: primary

mstewart8@northwell.edu

718-470-4667

Hye Jeong Jang

Role: backup

hjang3@northwell.edu

718-470-7983

References

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.

Reference Type: BACKGROUND

PMID: 31032096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32390697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8905371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32962331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23299137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20003966 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17474082 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24237949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26215646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26092615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31567785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25527056 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30725254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30705945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31759034 (View on PubMed)

Wannhoff A, Ruh N, Meier B, Riecken B, Caca K. Endoscopic gastrointestinal anastomoses with lumen-apposing metal stents: predictors of technical success. Surg Endosc. 2021 May;35(5):1997-2004. doi: 10.1007/s00464-020-07594-5. Epub 2020 May 1.

Reference Type: BACKGROUND

PMID: 32358692 (View on PubMed)

Itoi T, Ishii K, Ikeuchi N, Sofuni A, Gotoda T, Moriyasu F, Dhir V, Teoh AY, Binmoeller KF. Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction. Gut. 2016 Feb;65(2):193-5. doi: 10.1136/gutjnl-2015-310348. Epub 2015 Aug 17. No abstract available.

Reference Type: BACKGROUND

PMID: 26282674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27004243 (View on PubMed)

Khashab MA, Bukhari M, Baron TH, Nieto J, El Zein M, Chen YI, Chavez YH, Ngamruengphong S, Alawad AS, Kumbhari V, Itoi T. International multicenter comparative trial of endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for the treatment of malignant gastric outlet obstruction. Endosc Int Open. 2017 Apr;5(4):E275-E281. doi: 10.1055/s-0043-101695.

Reference Type: BACKGROUND

PMID: 28382326 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28697151 (View on PubMed)

Brewer Gutierrez OI, Nieto J, Irani S, James T, Pieratti Bueno R, Chen YI, Bukhari M, Sanaei O, Kumbhari V, Singh VK, Ngamruengphong S, Baron TH, Khashab MA. Double endoscopic bypass for gastric outlet obstruction and biliary obstruction. Endosc Int Open. 2017 Sep;5(9):E893-E899. doi: 10.1055/s-0043-115386. Epub 2017 Sep 13.

Reference Type: BACKGROUND

PMID: 28924596 (View on PubMed)

Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10.

Reference Type: BACKGROUND

PMID: 27834024 (View on PubMed)

Chen YI, James TW, Agarwal A, Baron TH, Itoi T, Kunda R, Nieto J, Bukhari M, Gutierrez OB, Sanaei O, Moran R, Fayad L, Khashab MA. EUS-guided gastroenterostomy in management of benign gastric outlet obstruction. Endosc Int Open. 2018 Mar;6(3):E363-E368. doi: 10.1055/s-0043-123468. Epub 2018 Mar 7.

Reference Type: BACKGROUND

PMID: 29527559 (View on PubMed)

Chen YI, Kunda R, Storm AC, Aridi HD, Thompson CC, Nieto J, James T, Irani S, Bukhari M, Gutierrez OB, Agarwal A, Fayad L, Moran R, Alammar N, Sanaei O, Canto MI, Singh VK, Baron TH, Khashab MA. EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques. Gastrointest Endosc. 2018 May;87(5):1215-1221. doi: 10.1016/j.gie.2017.07.030. Epub 2017 Jul 24.

Reference Type: BACKGROUND

PMID: 28750837 (View on PubMed)

Antonelli G, Kovacevic B, Karstensen JG, Kalaitzakis E, Vanella G, Hassan C, Vilmann P. Endoscopic ultrasound-guided gastro-enteric anastomosis: A systematic review and meta-analysis. Dig Liver Dis. 2020 Nov;52(11):1294-1301. doi: 10.1016/j.dld.2020.04.021. Epub 2020 Jun 3.

Reference Type: BACKGROUND

PMID: 32505567 (View on PubMed)

Fan W, Tan S, Wang J, Wang C, Xu H, Zhang L, Liu L, Fan Z, Tang X. Clinical outcomes of endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a systematic review and meta-analysis. Minim Invasive Ther Allied Technol. 2022 Feb;31(2):159-167. doi: 10.1080/13645706.2020.1792500. Epub 2020 Jul 16.

Reference Type: BACKGROUND

PMID: 32672479 (View on PubMed)

Other Identifiers

21-1130

Identifier Type: -

Identifier Source: org_study_id