Pancreatic Cancer Clinical Trial
Official title:
Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study
Verified date | March 2019 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 31, 2015 |
Est. primary completion date | April 30, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Preoperatively - Patients with stent treated tumor in the pancreatic head or periampullary planned for pancreaticoduodenectomy - The patient jaundice should have worn off and there should be no signs of duodenal obstruction - The patient has given informed consent after verbal and written information in accordance with approved ethics application - The patient has no anatomical conditions making endoscopic therapy impossible such as previous Billroth II or Gastric Bypass. 2. Intraoperatively - Peroperative findings of of carcinomatosis, metastases or local irresectability who oppose radical surgery - Surgical double bypass should be technically feasible - The patient has given informed consent after verbal and written information in accordance with approved ethics application Exclusion Criteria: - Peroperative signs of dysfunction on biliary stent - Peroperative findings of gastric outlet obstruction - Surgical double bypass not technically feasible |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Surgery, Sahlgrenska University Hospital | Gothenburg | |
Sweden | Department of surgery, University Hospital | Linköping | |
Sweden | Department of Surgery, Skane University Hospital | Lund | |
Sweden | Department of Surgery, University Hospital | Örebro | |
Sweden | Gastro Center Surgery, Karolinska University Hospital | Stockholm | |
Sweden | Department of Surgery, University Hospital | Umeå |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity | Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification. | Day 1-30 after randomization | |
Secondary | Quality of life | Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries | Preop, 1 month postop and every third month | |
Secondary | Numbers of readmissions to hospital | Up to two years after the laparotomy | ||
Secondary | The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions | The numbers of surgical, radiological or endoscopical interventions due to jaundice or gastric outlet obstruction from date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months" | Up to 24 months after the randomization |
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