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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTBD | Active Comparator | biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer |
|
| ERBD | Active Comparator | biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biliary drainage | Procedure | biliary drainage via PTBD or ERBD/ENBD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | within 120 days after drainage |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | within 14 days after drainage |
| Total Hospital Cost During Admission After Biliary Drainage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17352805 | Background | 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. | |
| 2439854 |
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144 patients and 68 patients were intended to be treated with ERBD/ENBD and PTBD, respectively. Among 144 patients, 39 patients were switched to PTBD due to a procedure failure. Finally, 104 and 107 patients were treated with ERBD/ENBD and PTBD, respectively. Clinical outcomes were compared on the basis on the final drainage method
Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | ERBD | biliary drainage : biliary drainage via ERBD/ENBD |
| FG001 | PTBD | biliary drainage : biliary drainage via PTBD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Total hospital cost during admission after Biliary Drainage in US dollars
| during hospital stay for biliary drainage procedure |
| Background |
| 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. |
| 12131081 | Background | 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. |
| 10561089 | Background | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ERBD | final biliary drainage procedure: biliary drainage via ERBD/ENBD |
| BG001 | PTBD | final biliary drainage procedure : biliary drainage via PTBD |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | participants | within 120 days after drainage |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Mean | Standard Deviation | mg/dL/day | within 14 days after drainage |
|
| ||||||||||||||||||||||||||||||
| Secondary | Total Hospital Cost During Admission After Biliary Drainage | Total hospital cost during admission after Biliary Drainage in US dollars | Posted | Mean | Standard Deviation | thousands in US dollars | during hospital stay for biliary drainage procedure |
|
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7 days after procedure such as PTBD and ENBD/ERBD per Intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTBD | final biliary drainage procedure: biliary drainage via PTBD Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting | 29 | 107 | 0 | 107 | ||
| EG001 | ERBD | final biliary drainage procedure: biliary drainage via ERBD/ENBD Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting | 23 | 104 | 0 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment | procedure associated bleeding event after PTBD or ENBD/ERBD |
| |
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment | Procedure associated pancreatitis after PTBD and ENBD/ERBD |
| |
| Cholangitis | Gastrointestinal disorders | Systematic Assessment | Procedure associated cholangitis after PTBD and ENBD/ERBD |
| |
| tube malfunction | Surgical and medical procedures | Systematic Assessment | tube malfunction which should be managed with additional procedure after PTBD and ENBD/ERBD |
| |
| Bile peritonitis | Gastrointestinal disorders | Systematic Assessment | Procedure associated peritonitis |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun-Whe Kim | Seoul National University College of Medicine | +82-2-2072-2315 | sunkim@plaza.snu.ac.kr |
| ID | Term |
|---|---|
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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