Malignant Gastric Outlet ObstructionNCT05986890
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
A study testing Roux-en-Y Bypass and gastrojejunostomy in people with Malignant Gastric Outlet Obstruction, run by Corewell Health West at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Gastric Outlet Obstruction
- What is being tested?
- Roux-en-Y Bypass and gastrojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Symptoms can include abdominal distention, abdominal pain, nausea and vomiting.
- 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.
Who cannot join
- Patients that have had previous treatment for malignant gastric outlet obstruction.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Malignant Gastric Outlet Obstruction
- Being tested
- Roux-en-Y Bypass, gastrojejunostomy
- Keywords
- MGOO, Malignant gastric outlet obstruction, gastric outlet, malignant tumor, proximal bowel obstruction, bowel obstruction
- Medical subject headings
- Neoplasms, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y BypassProcedure or surgery
laparoscopic Roux-en-Y
gastrojejunostomyProcedure or surgery
surgical gastrojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days post operative
Secondary outcomes (8)
Gastric emptying study at 30-days
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Measured: 30 days post operative
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.
Measured: 30 days postoperative
Number of Clavien-Dindo grade ≥3 adverse event
Measured: 14 days postoperative
Number of patients requiring reoperation for any indication
Measured: 30 days postoperative
number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
Measured: 30 days postoperative
Time from surgery to death
Measured: 100 days postoperative
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: measured pre-operatively, at 25-35 days post op and 80-100 days post op
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: measured pre-operatively, at 25-35 days post op and 80-100 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start17 Aug 2023
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Why it stopped: The study was terminated early due to poor participant accrual, resulting in inadequate enrollment to support the planned analysis and study endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Malignant Gastric Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald P. Wright, Corewell Health West
- Investigators
- G. Paul Wright, MD, Principal investigator, Corewell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986890
- Sponsor's protocol ID
- 2022-433
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weaver DW, Wiencek RG, Bouwman DL, Walt AJ. Gastrojejunostomy: is it helpful for patients with pancreatic cancer? Surgery. 1987 Oct;102(4):608-13.
PubMed 2443991Lillemoe 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.
PubMed 10493479Egrari S, O'Connell TX. Role of prophylactic gastroenterostomy for unresectable pancreatic carcinoma. Am Surg. 1995 Oct;61(10):862-4.
PubMed 7545358Del 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.
PubMed 15758914ROBINSON 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.
PubMed 13742310Doberneck 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.
PubMed 2439057Navarra 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.
PubMed 17063298Mintziras 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.
PubMed 31332564Johnsson 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.
PubMed 15457364Singh 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.
PubMed 1695834Lucas 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.
PubMed 7519417Mittal 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.
PubMed 14760669Bergamaschi 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.
PubMed 9566559Telford 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.
PubMed 15605006Jeurnink 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.
PubMed 20003966
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
- ClinicalTrials.gov ID
- NCT05986890
- Acronym / sponsor ID
- 2022-433
- Conditions
- Malignant Gastric Outlet Obstruction
- Keywords
- MGOO, Malignant gastric outlet obstruction, gastric outlet, malignant tumor, proximal bowel obstruction, bowel obstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to poor participant accrual, resulting in inadequate enrollment to support the planned analysis and study endpoints.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y Bypass | Other | Procedure: Roux-en-Y Bypasslaparoscopic 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. |
| Gastrojejunostomy | Other | Procedure: gastrojejunostomysurgical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- Patients that have had previous treatment for malignant gastric outlet obstruction.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y Bypasslaparoscopic Roux-en-Y | Procedure or surgery | Roux-en-Y Bypass |
| gastrojejunostomysurgical gastrojejunostomy | Procedure or surgery | Gastrojejunostomy |
Primary outcome
Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
Time frame: 7 days post operative
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
8 secondary outcomes
Gastric emptying study at 30-days
Time frame: 30 days post operative
Patient reported daily gastric outlet obstruction scoring system (GOOS) score
Time frame: 30 days postoperative
Number of Clavien-Dindo grade ≥3 adverse event
Time frame: 14 days postoperative
Number of patients requiring reoperation for any indication
Time frame: 30 days postoperative
number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
Time frame: 30 days postoperative
Time from surgery to death
Time frame: 100 days postoperative
Improvement of quality of life as measured by short form QOL Questionnaire
Time frame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
Improvement of quality of life as measured GIQLI
Time frame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
Results and safety
The study was stopped early (reason given: The study was terminated early due to poor participant accrual, resulting in inadequate enrollment to support the planned analysis and study endpoints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 2443991Weaver DW, Wiencek RG, Bouwman DL, Walt AJ. Gastrojejunostomy: is it helpful for patients with pancreatic cancer? Surgery. 1987 Oct;102(4):608-13.
- Background: PubMed 10493479Lillemoe 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.
- Background: PubMed 7545358Egrari S, O'Connell TX. Role of prophylactic gastroenterostomy for unresectable pancreatic carcinoma. Am Surg. 1995 Oct;61(10):862-4.
- Background: PubMed 15758914Del 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.
- Background: PubMed 13742310ROBINSON 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.
- Background: PubMed 2439057Doberneck 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.
- Background: PubMed 17063298Navarra 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.
- Background: PubMed 31332564Mintziras 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.
- Background: PubMed 15457364Johnsson 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.
- Background: PubMed 1695834Singh 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.
- Background: PubMed 7519417Lucas 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.
- Background: PubMed 14760669Mittal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Paul Wright, MD principal investigator
Corewell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Bypass and gastrojejunostomy in people with Malignant Gastric Outlet Obstruction, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to poor participant accrual, resulting in inadequate enrollment to support the planned analysis and study endpoints.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively. (time frame: 7 days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05986890, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.