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CompletedNCT01134276Updated Jun 11, 2014Results posted

Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

An interventional study of biliary drainage in Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer and Bile Duct Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-06-11.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
211
Allocation
Non-randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.

02

Conditions studied

  • Periampullary Cancers With Obstructive Jaundice
  • Pancreas Head Cancer
  • Bile Duct Cancer
  • Ampulla of Vater Cancer
03

In context

Bile Duct Neoplasms

217 studies on the registry are indexed under Bile Duct Neoplasms; 43 are open to participants now.

This study's enrollment of 211 is above the median of 50 across 161 interventional studies indexed under Bile Duct Neoplasms.

Browse Bile Duct Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient who have periampullary tumors causing obstructive jaundice
  • patient age: ≥20 and ≤85
  • resectable state of disease
  • no history of previous chemotherapy or radiotherapy
  • patients without uncontrollable severe cardiovascular, respiratory disease
  • Karnofsky performance scale ≥70
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • patients with distant metastasis or locally advanced disease with major vascular invasion
  • duodenal cancer
  • biliary drainage before randomization
  • previous chemotherapy or radiotherapy
  • uncontrollable active infection except cholangitis
  • severe comorbid disease (cardiac, pulmonary, cerebrovascular)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
211 participants (actual)

Study arms

  • Active comparator
    PTBD

    biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer

    Procedure: biliary drainage

  • Active comparator
    ERBD

    biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer

    Procedure: biliary drainage

Interventions

  • Procedurebiliary drainage

    biliary drainage via PTBD or ERBD/ENBD

06

What researchers measure

Primary outcomes

  1. Incidence of Infectious Complications After Biliary Drainage

    at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)

    Time frame: within 120 days after drainage

Secondary outcomes

  1. Change in Total Serum Bilirubin After Drainage

    Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)

    Time frame: within 14 days after drainage

  2. Total Hospital Cost During Admission After Biliary Drainage

    Total hospital cost during admission after Biliary Drainage in US dollars

    Time frame: during hospital stay for biliary drainage procedure

07

Results

Posted Jun 11, 2014

Participant flow

Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.

Participant flow — Overall Study
MilestoneERBDPTBD
Started104107
Completed104107
Not completed00

Outcome measures

PrimaryIncidence of Infectious Complications After Biliary Drainage

at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)

Time frame:
within 120 days after drainage
Reported as:
Number · participants
Incidence of Infectious Complications After Biliary Drainage
participantsPTBDERBD
Incidence of Infectious Complications After Biliary Drainage115
SecondaryChange in Total Serum Bilirubin After Drainage

Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)

Time frame:
within 14 days after drainage
Reported as:
Mean · mg/dL/day
Change in Total Serum Bilirubin After Drainage
mg/dL/dayPTBDENBD/ERBD
Change in Total Serum Bilirubin After Drainage0.7 ± 0.50.6 ± 0.4
SecondaryTotal Hospital Cost During Admission After Biliary Drainage

Total hospital cost during admission after Biliary Drainage in US dollars

Time frame:
during hospital stay for biliary drainage procedure
Reported as:
Mean · thousands in US dollars
Total Hospital Cost During Admission After Biliary Drainage
thousands in US dollarsPTBDERBD
Total Hospital Cost During Admission After Biliary Drainage16.0 ± 5.917.0 ± 7.5

Adverse events

Collected over 7 days after procedure such as PTBD and ENBD/ERBD per Intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PTBD—29/107 (27.1%)0/107 (0%)
ERBD—23/104 (22.1%)0/104 (0%)
Most frequent serious events
Most frequent serious events
EventPTBDERBD
PancreatitisGastrointestinal disorders3/10717/104
CholangitisGastrointestinal disorders9/1075/104
tube malfunctionSurgical and medical procedures9/1077/104
BleedingBlood and lymphatic system disorders6/1073/104
Bile peritonitisGastrointestinal disorders2/1070/104

Baseline characteristics

Age, Continuous
Age, Continuous(years)ERBDPTBDTotal
Mean66.3 ± 8.663.5 ± 9.064.8 ± 8.9
Sex: Female, Male
Sex: Female, Male(Participants)ERBDPTBDTotal
Female334275
Male7165136
Region of Enrollment
Region of Enrollment(participants)ERBDPTBDTotal
Korea, Republic of104107211
08

Study locations

1 site
  • Department of Surgery, Seoul National University Hospital
    Seoul, Korea, Republic of
09

References and documents

Publications

  • van der Gaag NA, de Castro SM, Rauws EA, Bruno MJ, van Eijck CH, Kuipers EJ, Gerritsen JJ, Rutten JP, Greve JW, Hesselink EJ, Klinkenbijl JH, Rinkes IH, Boerma D, Bonsing BA, van Laarhoven CJ, Kubben FJ, van der Harst E, Sosef MN, Bosscha K, de Hingh IH, Th de Wit L, van Delden OM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial). BMC Surg. 2007 Mar 12;7:3. doi: 10.1186/1471-2482-7-3. PubMed 17352805 ↗
  • Speer AG, Cotton PB, Russell RC, Mason RR, Hatfield AR, Leung JW, MacRae KD, Houghton J, Lennon CA. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987 Jul 11;2(8550):57-62. doi: 10.1016/s0140-6736(87)92733-4. PubMed 2439854 ↗
  • Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005. PubMed 12131081 ↗
  • Saiki S, Chijiiwa K, Komura M, Yamaguchi K, Kuroki S, Tanaka M. Preoperative internal biliary drainage is superior to external biliary drainage in liver regeneration and function after hepatectomy in obstructive jaundiced rats. Ann Surg. 1999 Nov;230(5):655-62. doi: 10.1097/00000658-199911000-00007. PubMed 10561089 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01134276
Lead sponsor
Seoul National University Hospital
Responsible party
Sun-Whe Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
May 31, 2010
Start date
Aug 2010
Primary completion
May 2013
Completion
May 2013
Results posted
Jun 11, 2014
Last update
Jun 11, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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