Preoperative biliary drainage for pancreato-biliary tumors causing obstructive jaundice; DRainage vs Operation.

Patients with obstructive jaundice caused by a tumor in the pancreatic head area (pancreas, papilla, distal bile duct) undergo several diagnostic procedures to evaluate resectability of the tumor. If no metastases or local tumor ingrowth in the portal vein is found these patients are eligible for resection, the only chance for cure. Unfortunately, surgery in these jaundiced patients is associated with a higher risk of postoperative complications compared with surgery in non jaundiced patients.
Therefore preoperative biliary drainage was introduced in an attempt to improve general condition (liver function, renal function, nutritional status and immune response) and by that reduce postoperative morbidity and mortality.
Later on, the focus has shifted towards the negative effects of drainage, such as an increase of infectious complications. This has raised doubts as to whether a biliary drainage should always be performed in these patients.

Despite this controversy in management preoperative biliary drainage is generally accepted in the Netherlands partly because ERCP has been used in the past as the first diagnostic procedure and for other logistic reasons (to have more time for further investigation).

The therapeutic dilemma remains whether or not these jaundiced patients should have preoperative biliary drainage. The proposed project involves a randomized multicenter trial to compare the outcome of “a preoperative biliary drainage strategy” (standard strategy) with that of an “early surgery” strategy, with respect to the incidence of severe complications (primary outcome measure), hospital stay, number of invasive diagnostic tests and costs.

Early surgical treatment (exploration followed by resection (pancreatoduodenectomy or bypass) in patients with obstructive jaundice due to a pancreatic head tumor is equivalent in terms of severe complications of treatment compared with patients who underwent preoperative biliary drainage (4 weeks) and subsequent surgery, while reducing hospital stay, the number of invasive diagnostic procedures (ERCP) and results in lower overall costs.

N/A

1. Preoperative biliary drainage: Drainage procedure will be performed within three days after randomization for a total of 4 weeks;

2. ERCP and preoperative biliary drainage will be performed by an experienced endoscopist, preferably by endoscopically insertion of a (plastic)stent;

3. One stent is generally sufficient because only distal obstruction is included;

4. If ERCP is not successful, patient can be referred to a center for a second attempt for endoscopic drainage or a percutaneous drainage will be performed according to local experience;

5. Biliary drainage is considered adequate if a decrease of > 50% of serum bilirubin level is found after 2 weeks of drainage; otherwise the stent should be changed;

6. Exactly four weeks of preoperative biliary drainage patients will undergo surgery. In case of complications after ERCP or during the biliary drainage period (cholangitis, stent occlusion) a stent exchange will be performed;

7. Other complications, such as bleeding or severe pancreatitis, should be treated according to the general locally accepted treatment protocol and/or consensus about management (46,47) and could consequently lead to a delay of surgery;

8. Preoperative nutritional support (e.g. consultation with a dietician, nutirdrink, ) is recommended in patients with a weight loss of more than 15% during the last 3 months.



Surgical treatment: Surgery will be performed within one week after randomization. Guidelines for exploration and treatment are described below

9. Surgery should be planned keeping in mind that the maximum estimated bilirubin level (> 40 µmol/l and < 250 µmol/l at randomization) must not exceed 300µmol/l, 24 Hours before surgery. (e.g. high bilirubine at randomization requires earlier surgery);

10. Vitamine K (10 mg, oral, 1 day preoperatively) is given on indication and cefuroxim (1500 mg, intravenous single shot, ½ hour preoperatively) and Sandostatine (or other analogues) (3x 100 μg, subcutaneous, 12 hours before surgery and continued for seven days after surgery) as profylaxis;

11. During exploration the standard procedure will be the standard pylorus preserving pancreatoduodenectomy(46,47) as previously described (removal lymph nodes right side of portal vein5,33)) If indicated (suspicious ingrowth proximal duodenum/pylorus) a Whipple procedure can be performed. In case of minimal vascular ingrowth a wedge resection of the portal/mesenteric vein can be performed (33,36);

12. Reconstruction is performed by pancreaticojejunostomy, a hepaticojejunostomy and gastrojejunostomy (5,33);

13. One silicone drain is placed near the pancreaticojejunostomy and/or one near the hepaticojejunostomy; T-drains will not be used;

14. A feeding jejunostomy is not to be used as standard treatment;

15. If resection is not performed due to metastases or local ingrowth biopsies have to be taken.
Palliative treatment should be performed by a hepaticojejunostomy with gastroenterostomy plus a celiac plexus blockade (7,8,33). If a hepaticojejunostomy is not possible a Wallstent should be placed during a postoperative ERCP session.