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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health West

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Roux-en-Y Bypass

    Procedure/Surgery

    laparoscopic Roux-en-Y

  • gastrojejunostomy

    Procedure/Surgery

    surgical gastrojejunostomy

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Roux-en-Y BypassOther 1 intervention
Group B: GastrojejunostomyOther 1 intervention

Trial outcomes

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

Time frame
7 days post operative

Secondary outcomes

1

Gastric emptying study at 30-days

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

Time frame
30 days post operative
2

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.

Time frame
30 days postoperative
3

Number of Clavien-Dindo grade ≥3 adverse event

Time frame
14 days postoperative
4

Number of patients requiring reoperation for any indication

Time frame
30 days postoperative

Other outcomes

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