An interventional study of Tannenbaum Fr 10 stent or WallFlex stent in Pancreatic Cancer and Biliary Stasis, sponsored by Helsinki University Central Hospital. Withdrawn at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group proceed to pancreatic resection within 2 week of recruitment.
Endoscopic retrograde cholangiopancreatography (ERCP) is used to place an endoprosthesis to the biliary ducts to drain biliary stasis, and the patients proceed to pancreatic resection within 6 weeks of recruitment.
Device: Tannenbaum Fr 10 stent or WallFlex stent
A plastic or metallic endoprosthesis is placed to the biliary ducts.
Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery
Time frame: 120 days after surgery
Plan to share: No
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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