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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05986890
Other study ID # 2022-433
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2023
Est. completion date December 1, 2025

Study information

Verified date January 2024
Source Spectrum Health Hospitals
Contact G. Paul Wright, MD
Phone 616-486-6333
Email paul.wright@corewellhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Malignant gastric outlet obstruction is when malignant tumor growth obstructs the gastric outlet at the level of the distal stomach or duodenum, causing food intolerance with nausea and vomiting. Most often, this signifies advanced neoplastic disease with associated poor prognosis for patients. Restoring patients to oral intake is important for palliative purposes. The current standard of care in patients requiring long-term alleviation of symptoms (≥2 months) is performing a loop gastrojejunostomy. This involves creating an intestinal bypass to the site of obstruction in the duodenum or distal stomach. This procedure has long been criticized for its poor resultant function for patients, mainly due to poor tolerance to food intake that include frequent episodes of nausea and vomiting and inability to for solid food intake. The need for a durable solution to malignant gastric outlet obstruction that provides better tolerance to solid food intake is evident. The roux-en-y gastric bypass procedure has been performed for a variety of indications for decades, most commonly for weight loss but also with oncologic resections of the stomach in cases of gastric cancer. Laparoscopic roux-en-y gastric bypass (R-Y bypass) has become the standard for this procedure in experienced hands and has been found to be safe in the short- and long term. The long-term function after R-Y bypass is generally favorable across published literature. No studies exist to compare loop gastrojejunostomy to roux-en-y gastric bypass in patients with malignant gastric outlet obstruction.


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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Roux-en-Y Bypass
laparoscopic Roux-en-Y
gastrojejunostomy
surgical gastrojejunostomy

Locations

Country Name City State
United States G. Paul Wright Grand Rapids Michigan

Sponsors (1)

Lead Sponsor Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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 Gastric emptying study at 30-days Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients 30 days post operative
Secondary Patient reported daily gastric outlet obstruction scoring system (GOOS) score Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting. 30 days postoperative
Secondary Number of Clavien-Dindo grade =3 adverse event 14 days postoperative
Secondary Number of patients requiring reoperation for any indication 30 days postoperative
Secondary number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery 30 days postoperative
Secondary Time from surgery to death 100 days postoperative
Secondary Improvement of quality of life as measured by short form QOL Questionnaire The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life measured pre-operatively, at 25-35 days post op and 80-100 days post op
Secondary Improvement of quality of life as measured GIQLI The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life measured pre-operatively, at 25-35 days post op and 80-100 days post op
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05564143 - Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction N/A
Recruiting NCT06128018 - Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO. N/A
Recruiting NCT04810377 - Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction N/A
Withdrawn NCT04375462 - AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients N/A
Recruiting NCT02440724 - The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents N/A