Clinical trial · Interventional
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampulla of Vater Cancer | Malignant Ampulla of Vater Neoplasm | CURATED_BROADER | 0.80 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Pancreas Head Cancer | — | UNRESOLVED | — |
| Periampullary Cancers With Obstructive Jaundice | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biliary drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PTBD
- description
- biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
- interventionNames
- Procedure: biliary drainage
- type
- ACTIVE_COMPARATOR
- label
- ERBD
- description
- biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
- interventionNames
- Procedure: biliary drainage
Primary outcomes (1)
- measure
- Incidence of Infectious Complications After Biliary Drainage
- timeFrame
- within 120 days after drainage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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: * 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)
References
Publications (4)
- BACKGROUNDvan 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. PMID 17352805
- BACKGROUNDSpeer 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. PMID 2439854
- BACKGROUNDSewnath 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. PMID 12131081
- BACKGROUNDSaiki 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. PMID 10561089