Mehta 2006.
Methods | Single‐centre randomised controlled study | |
Participants | 27 participants with malignant GOO and unresectable or advanced metastatic malignancy (or both) who were fit for intervention. Primary site of malignancy: pancreatic (56%), gastric (15%), cholangiocarcinoma (7%), gallbladder (3.5%) and metastatic disease (15%). 1 participant (3.5%) was subsequently found to have a benign gastric ulcer, as opposed to an underlying malignancy, as the cause of the GOO. Men: 13/27 (48%) Mean age: 68.9 years |
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Interventions | 14 participants randomised to gastrojejunostomy. 13 participants underwent the procedure (1 participant died prior to the intervention). Further details: laparoscopic, antecolic gastrojejunostomy with stapled gastrojejunal anastomosis. The 2 surgeons involved in the study had undertaken laparoscopic gastrojejunostomy for 10 years and had completed over 50 cases prior to the study. 13 participants randomised to duodenal stenting. Stents were unable to be passed in 2 participants and they went on to have a gastrojejunostomy. Further details: enteral Wallstent (Boston Scientific, Natick, MA, USA) inserted either orally (8 participants) or via a percutaneous gastrostomy tract (3 participants). The radiology team had performed 21 duodenal stents prior to the study. 6 participants in the gastrojejunostomy group and 7 participants in the duodenal stenting group also underwent biliary decompression by either endoscopic retrograde cholangiopancreatography or percutaneous transhepatic cholangiography prior to the operation. |
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Outcomes |
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Notes | All participants in the study presented with typical symptoms of nausea, vomiting and abdominal pain, with confirmation of diagnosis by gastroscopy, contrast swallow or computerised tomography. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using a computer‐generated list concealed from the investigators at the time of enrolment." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was performed using a computer‐generated list concealed from the investigators at the time of enrolment." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants consented to both treatment options prior to allocation, but would have been aware of the intervention they received. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: information not available |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "6 patients in the laparoscopic gastrojejunostomy group and 7 patients in the duodenal stenting group completed questionnaires at 1 month." Comment: therefore, 7 participants did not complete questionnaires at 1 month and the reasons were not documented. |
Selective reporting (reporting bias) | Low risk | Comment: all important outcomes reported |
Other bias | Low risk | Comment: no other source of bias identified. Participants were well matched for age, sex and weight. Unclear how well matched the 2 groups were for site of primary malignancy |
GOO: gastric outlet obstruction; SF‐36: 36‐item Short Form Health Survey.