Pancreatic Cancer, Periampullary Tumor
Conditions
Keywords
Surgical bypass, Hepaticojejunostomy, Gastrojejunostomy, Biliary stent, Enteral stent
Brief summary
Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.
Interventions
PROCEDUREHepaticojejunostomy and gastroenterostomy
Standard surgical techniques
PROCEDUREStent strategy
Biliary and/or enteral stents on demand
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | Day 1-30 after randomization | Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Preop, 1 month postop and every third month | Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries |
| Numbers of readmissions to hospital | Up to two years after the laparotomy | — |
| The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions | Up to 24 months after the randomization | 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 |
Countries
Sweden
Outcome results
None listed