Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

NCT05986890 | Recruiting

• 1 other identifier: 2022-433
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to investigate whether roux-en-y bypass surgery is superior to conventional loop gastrojejunostomy for Malignant gastric outlet obstruction in terms of tolerance to solid food intake. We hypothesize that roux-en-y bypass will be associated with improved solid food intake in the first 30 days after surgery.

Conditions

Malignant Gastric Outlet Obstruction

Keywords

MGOO; Malignant gastric outlet obstruction; gastric outlet; malignant tumor; proximal bowel obstruction; bowel obstruction

Outcome Measures

Primary Outcomes (1)

• Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.

  Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients

  7 days post operative

Secondary Outcomes (8)

• Gastric emptying study at 30-days

  30 days post operative

• Patient reported daily gastric outlet obstruction scoring system (GOOS) score

  30 days postoperative

• Number of Clavien-Dindo grade ≥3 adverse event

  14 days postoperative

• Number of patients requiring reoperation for any indication

  30 days postoperative

• number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery

  30 days postoperative

Study Arms (2)

Roux-en-Y Bypass

OTHER

laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.

Procedure: Roux-en-Y Bypass

Gastrojejunostomy

OTHER

surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.

Procedure: gastrojejunostomy

Interventions

Roux-en-Y Bypass PROCEDURE

laparoscopic Roux-en-Y

Roux-en-Y Bypass

gastrojejunostomy PROCEDURE

surgical gastrojejunostomy

Gastrojejunostomy

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female aged ≥18 years old.
• Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined as malignant cancer growth of any organ origin in the area of the distal stomach or duodenum preventing normal gastric emptying as determined by symptoms and cross-sectional imaging studies.
• ii. Symptoms can include abdominal distention, abdominal pain, nausea and vomiting.
• iii. Cross sectional imaging findings can include tumor growth in the area of the distal stomach or duodenum, gastric distention, fluid filled stomach and decompressed bowel distal to obstruction point.
• Patients deemed to benefit from surgical bypass as opposed to stent placement, by the primary surgeon. This includes assessing participants survival chances and ability to undergo a surgical procedure.
• Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist.

You may not qualify if:

• Patients that have had previous treatment for malignant gastric outlet obstruction.
• a. Including any previous surgery or stent placement for MGOO
• Patients with MGOO deemed to benefit more from endoscopic stent placement rather than surgery for symptom relief. This assessment will be at treating surgeon's discretion.

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

G. Paul Wright

Grand Rapids, Michigan, 49503, United States

RECRUITING

Related Publications (28)

• Weaver DW, Wiencek RG, Bouwman DL, Walt AJ. Gastrojejunostomy: is it helpful for patients with pancreatic cancer? Surgery. 1987 Oct;102(4):608-13.

  PMID: 2443991 BACKGROUND

• Lillemoe KD, Cameron JL, Hardacre JM, Sohn TA, Sauter PK, Coleman J, Pitt HA, Yeo CJ. Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial. Ann Surg. 1999 Sep;230(3):322-8; discussion 328-30. doi: 10.1097/00000658-199909000-00005.

  PMID: 10493479 BACKGROUND

• Egrari S, O'Connell TX. Role of prophylactic gastroenterostomy for unresectable pancreatic carcinoma. Am Surg. 1995 Oct;61(10):862-4.

  PMID: 7545358 BACKGROUND

• Del Piano M, Ballare M, Montino F, Todesco A, Orsello M, Magnani C, Garello E. Endoscopy or surgery for malignant GI outlet obstruction? Gastrointest Endosc. 2005 Mar;61(3):421-6. doi: 10.1016/s0016-5107(04)02757-9.

  PMID: 15758914 BACKGROUND

• ROBINSON JO. The history of gastric surgery. Postgrad Med J. 1960 Dec;36(422):706-13. doi: 10.1136/pgmj.36.422.706. No abstract available.

  PMID: 13742310 BACKGROUND

• Doberneck RC, Berndt GA. Delayed gastric emptying after palliative gastrojejunostomy for carcinoma of the pancreas. Arch Surg. 1987 Jul;122(7):827-9. doi: 10.1001/archsurg.1987.01400190093020.

  PMID: 2439057 BACKGROUND

• Navarra G, Musolino C, Venneri A, De Marco ML, Bartolotta M. Palliative antecolic isoperistaltic gastrojejunostomy: a randomized controlled trial comparing open and laparoscopic approaches. Surg Endosc. 2006 Dec;20(12):1831-4. doi: 10.1007/s00464-005-0454-5.

  PMID: 17063298 BACKGROUND

• Mintziras I, Miligkos M, Wachter S, Manoharan J, Bartsch DK. Palliative surgical bypass is superior to palliative endoscopic stenting in patients with malignant gastric outlet obstruction: systematic review and meta-analysis. Surg Endosc. 2019 Oct;33(10):3153-3164. doi: 10.1007/s00464-019-06955-z. Epub 2019 Jul 22.

  PMID: 31332564 BACKGROUND

• Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.

  PMID: 15457364 BACKGROUND

• Singh SM, Longmire WP Jr, Reber HA. Surgical palliation for pancreatic cancer. The UCLA experience. Ann Surg. 1990 Aug;212(2):132-9. doi: 10.1097/00000658-199008000-00003.

  PMID: 1695834 BACKGROUND

• Lucas CE, Ledgerwood AM, Saxe JM, Bender JS, Lucas WF. Antrectomy. A safe and effective bypass for unresectable pancreatic cancer. Arch Surg. 1994 Aug;129(8):795-9. doi: 10.1001/archsurg.1994.01420320017001.

  PMID: 7519417 BACKGROUND

• Mittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396.

  PMID: 14760669 BACKGROUND

• Bergamaschi R, Marvik R, Thoresen JE, Ystgaard B, Johnsen G, Myrvold HE. Open versus laparoscopic gastrojejunostomy for palliation in advanced pancreatic cancer. Surg Laparosc Endosc. 1998 Apr;8(2):92-6.

  PMID: 9566559 BACKGROUND

• Telford JJ, Carr-Locke DL, Baron TH, Tringali A, Parsons WG, Gabbrielli A, Costamagna G. Palliation of patients with malignant gastric outlet obstruction with the enteral Wallstent: outcomes from a multicenter study. Gastrointest Endosc. 2004 Dec;60(6):916-20. doi: 10.1016/s0016-5107(04)02228-x.

  PMID: 15605006 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.

  PMID: 20003966 BACKGROUND

• Upchurch E, Ragusa M, Cirocchi R. Stent placement versus surgical palliation for adults with malignant gastric outlet obstruction. Cochrane Database Syst Rev. 2018 May 30;5(5):CD012506. doi: 10.1002/14651858.CD012506.pub2.

  PMID: 29845610 BACKGROUND

• National Comprehensive Cancer Network. Pancreatic Adenocarcinoma, Version 1.2020. Published 2019. Accessed May 8, 2020. www2.tri-kobe/nccn/guideline/pancreas/english/pancreatic.pdf

  BACKGROUND

• He L, Zhao Y. Is Roux-en-Y or Billroth-II reconstruction the preferred choice for gastric cancer patients undergoing distal gastrectomy when Billroth I reconstruction is not applicable? A meta-analysis. Medicine (Baltimore). 2019 Nov;98(48):e17093. doi: 10.1097/MD.0000000000017093.

  PMID: 31770192 BACKGROUND

• Okuno K, Nakagawa M, Kojima K, Kanemoto E, Gokita K, Tanioka T, Inokuchi M. Long-term functional outcomes of Roux-en-Y versus Billroth I reconstructions after laparoscopic distal gastrectomy for gastric cancer: a propensity-score matching analysis. Surg Endosc. 2018 Nov;32(11):4465-4471. doi: 10.1007/s00464-018-6192-2. Epub 2018 Apr 13.

  PMID: 29654529 BACKGROUND

• Nakanishi K, Kanda M, Ito S, Mochizuki Y, Teramoto H, Ishigure K, Murai T, Asada T, Ishiyama A, Matsushita H, Shimizu D, Tanaka C, Kobayashi D, Fujiwara M, Murotani K, Kodera Y. Propensity-score-matched analysis of a multi-institutional dataset to compare postoperative complications between Billroth I and Roux-en-Y reconstructions after distal gastrectomy. Gastric Cancer. 2020 Jul;23(4):734-745. doi: 10.1007/s10120-020-01048-6. Epub 2020 Feb 17.

  PMID: 32065304 BACKGROUND

• Edholm D. Early intake of solid food after Roux-en-Y gastric bypass and complications. A cohort study from the Scandinavian Obesity Surgery Registry. Surg Obes Relat Dis. 2018 Sep;14(9):1256-1260. doi: 10.1016/j.soard.2018.05.023. Epub 2018 Jun 6.

  PMID: 30001890 BACKGROUND

• Potts JR 3rd, Broughan TA, Hermann RE. Palliative operations for pancreatic carcinoma. Am J Surg. 1990 Jan;159(1):72-7; discussion 77-8. doi: 10.1016/s0002-9610(05)80609-9.

  PMID: 1688485 BACKGROUND

• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

  PMID: 21561347 BACKGROUND

• Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

  PMID: 24131140 BACKGROUND

• Osland E, Yunus RM, Khan S, Alodat T, Memon B, Memon MA. Postoperative Early Major and Minor Complications in Laparoscopic Vertical Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) Procedures: A Meta-Analysis and Systematic Review. Obes Surg. 2016 Oct;26(10):2273-84. doi: 10.1007/s11695-016-2101-8.

  PMID: 26894908 BACKGROUND

• Peterli R, Borbely Y, Kern B, Gass M, Peters T, Thurnheer M, Schultes B, Laederach K, Bueter M, Schiesser M. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Ann Surg. 2013 Nov;258(5):690-4; discussion 695. doi: 10.1097/SLA.0b013e3182a67426.

  PMID: 23989054 BACKGROUND

• Young MT, Gebhart A, Phelan MJ, Nguyen NT. Use and Outcomes of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Gastric Bypass: Analysis of the American College of Surgeons NSQIP. J Am Coll Surg. 2015 May;220(5):880-5. doi: 10.1016/j.jamcollsurg.2015.01.059. Epub 2015 Feb 16.

  PMID: 25907869 BACKGROUND

• Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.

  PMID: 17981197 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Intestinal Obstruction

Interventions

Anastomosis, Roux-en-Y; Gastric Bypass

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy

Study Officials

• G. Paul Wright, MD

  Corewell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G. Paul Wright, MD

CONTACT

616-486-6333; paul.wright@corewellhealth.org

Cindy Cheung, BS

CONTACT

6164860990; cindy.cheung@corewellhealth.org

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: Surgical Oncology and Hepatopancreaticobiliary Surgeon

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 17, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)