Preoperative biliary drainage for pancreato-biliary tumours causing obstructive jaundice: DRainage versus OPeration

ISRCTN ISRCTN31939699
DOI https://doi.org/10.1186/ISRCTN31939699
Secondary identifying numbers NTR234
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
18/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr N A van der Gaag
Scientific

Academic Medical Centre
Department of Surgery
Meibergdreef 9
P.O. Box 226600
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5662661
Email n.a.vandergaag@amc.uva.nl

Study information

Study designRandomised active controlled parallel group multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymDROP-trial
Study objectivesEarly surgical treatment (exploration followed by resection [pancreatoduodenectomy] or bypass) in patients with obstructive jaundice due to a pancreatic head tumour is equivalent in terms of severe complications of treatment compared with patients who underwent preoperative biliary drainage (four weeks) and subsequent surgery, while reducing hospital stay, the number of invasive diagnostic procedures (Endoscopic Retrograde Cholangiopancreatography [ERCP]) and results in lower overall costs.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedJaundice, bile duct tumour, pancreas tumour, Papilla of Vater tumour
InterventionPreoperative biliary drainage:
Drainage procedure will be performed within three days after randomisation for a total of four weeks.

1. ERCP and preoperative biliary drainage will be performed by an experienced endoscopist, preferably by endoscopically insertion of a (plastic) stent
2. One stent is generally sufficient because only distal obstruction is included
3. If ERCP is not successful, patient can be referred to a centre for a second attempt for endoscopic drainage or a percutaneous drainage will be performed according to local experience
4. Biliary drainage is considered adequate if a decrease of greater than 50% of serum bilirubin level is found after two weeks of drainage; otherwise the stent should be changed
5. 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.
6. Other complications, such as bleeding or severe pancreatitis, should be treated according to the general locally accepted treatment protocol and/or consensus about management and could consequently lead to a delay of surgery
7. Preoperative nutritional support (e.g. consultation with a dietician, nutri-drink) is recommended in patients with a weight loss of more than 15% during the last three months

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

1. Surgery should be planned keeping in mind that the maximum estimated bilirubin level (greater than 40 µmol/l and less than 250 µmol/l at randomization) must not exceed 300 µmol/l, 24 hours before surgery (e.g. high bilirubin at randomization requires earlier surgery)
2. Vitamin K (10 mg, oral, one day preoperatively) is given on indication and cefuroxim (1500 mg, intravenous single shot, ½ hour preoperatively) and sandostatin (or other analogues) (three times 100 µg, subcutaneous, 12 hours before surgery and continued for seven days after surgery) as prophylaxis
3. During exploration the standard procedure will be the standard pylorus preserving pancreatoduodenectomy as previously described (removal lymph nodes right side of portal vein). 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
4. Reconstruction is performed by pancreaticojejunostomy, a hepaticojejunostomy and gastrojejunostomy
5. One silicone drain is placed near the pancreaticojejunostomy and/or one near the hepaticojejunostomy; T-drains will not be used
6. A feeding jejunostomy is not to be used as standard treatment
7. 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. If a hepaticojejunostomy is not possible a wall stent should be placed during a postoperative ERCP session.

Please note that the anticipated end date of this trial has been extended to the 1st November 2007.
Intervention typeOther
Primary outcome measurePercentage of patients with severe complications due to drainage or postoperative within 120 days after randomisation (90 days after surgery).
Secondary outcome measures1. Hospital stay
2. Number of extra invasive diagnostic procedures
3. Costs
4. Quality of life
5. Analysis of CT criteria for resectability
Overall study start date01/11/2003
Completion date01/11/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants210
Key inclusion criteria1. Clinical diagnosis of obstructive jaundice due to a pancreatic head or periampullary tumour
2. A serum bilirubin level of greater than 40 µmol/l and less than 250 µmol/l at randomisation
3. A spiral Computed Tomography (CT) scan according to standard protocol without metastases or local tumour ingrowth in the portal or mesenteric vessels of greater than 180°
4. Referred for surgical treatment to one of the participating centres
5. Time between CT and randomisation less than or equal to four days
6. Informed consent
Key exclusion criteria1. Aged greater than 85 years or severe co-morbidity (Karnofsky less than 50%) and other contra-indications for major surgery
2. Cholangitis/infection
3. Previous ERCP and stenting or percutaneous biliary drainage
4. Previous chemotherapy for this malignancy
5. Severe gastric outlet obstruction (stenosis duodenum due to tumour growth) defined as vomiting, nausea and/or oral intake less than 1 l/day
Date of first enrolment01/11/2003
Date of final enrolment01/11/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 12/03/2007 Yes No
Results article results 14/01/2010 Yes No