Clinical trial · Interventional
The Effect of Application of TachoSil® in Pancreatoduodenectomy
The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
NCT03269955CI-TRIAL-00029390unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group. Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Bordeline Tumor | — | UNRESOLVED | — |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Periampullary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fibrinogen/thrombin-coated collagen patch | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- application of TachoSil®
- description
- Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy
- interventionNames
- Drug: Fibrinogen/thrombin-coated collagen patch
- type
- NO_INTERVENTION
- label
- control
- description
- Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.
Primary outcomes (2)
- measure
- Incidence of pancreatic fistula
- timeFrame
- At 3 days after surgery
- description
- The evaluation of the pancreatic fistula was based on the international study group of pancreatic fistula (ISGPF). According to the criteria, evaluation of pancreatic fistula was evaluated by measuring the amylase level of the drain tube on the third postoperative day, and the pancreatic fistula was judged to be present when the amylase level was three times higher than the normal level of the amylase in the blood.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG performance score of 0-2 * Periampulary cancer or borderline tumor that is able to resection on preoperative examination * Patients without distance metastasis * Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3 * Liver function: AST/ALT less than 3 times upper limit of normal * Kidney function: Creatinine no greater than 1.5 times upper limit of normal * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with distant metastases are not eligible * Recurred periampulary cancer * Pregnant and breastfeeding women * Patients with active or uncontrolled infection * Patients with uncontrolled heart disease * Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart failure, etc.) * Patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)
References
Publications (16)
- BACKGROUNDSuzuki Y, Fujino Y, Ajiki T, Ueda T, Sakai T, Tanioka Y, Kuroda Y. No mortality among 100 consecutive pancreaticoduodenectomies in a middle-volume center. World J Surg. 2005 Nov;29(11):1409-14. doi: 10.1007/s00268-005-0152-4. PMID 16222456
- BACKGROUNDBassi C, Butturini G, Molinari E, Mascetta G, Salvia R, Falconi M, Gumbs A, Pederzoli P. Pancreatic fistula rate after pancreatic resection. The importance of definitions. Dig Surg. 2004;21(1):54-9. doi: 10.1159/000075943. Epub 2003 Dec 30. PMID 14707394
- BACKGROUNDBenzoni E, Zompicchiatti A, Saccomano E, Lorenzin D, Baccarani U, Adani G, Noce L, Uzzau A, Cedolini C, Bresadola F, Intini S. Postoperative complications linked to pancreaticoduodenectomy. An analysis of pancreatic stump management. J Gastrointestin Liver Dis. 2008 Mar;17(1):43-7. doi: 10.1007/s11749-008-0106-x. PMID 18392243
- BACKGROUNDde Castro SM, Kuhlmann KF, Busch OR, van Delden OM, Lameris JS, van Gulik TM, Obertop H, Gouma DJ. Incidence and management of biliary leakage after hepaticojejunostomy. J Gastrointest Surg. 2005 Nov;9(8):1163-71; discussion 1171-3. doi: 10.1016/j.gassur.2005.08.010. PMID 16269388
- BACKGROUNDBassi C, Falconi M, Molinari E, Mantovani W, Butturini G, Gumbs AA, Salvia R, Pederzoli P. Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery. 2003 Nov;134(5):766-71. doi: 10.1016/s0039-6060(03)00345-3. PMID 14639354
- BACKGROUNDGovindarajan A, Tan JC, Baxter NN, Coburn NG, Law CH. Variations in surgical treatment and outcomes of patients with pancreatic cancer: a population-based study. Ann Surg Oncol. 2008 Jan;15(1):175-85. doi: 10.1245/s10434-007-9601-7. Epub 2007 Oct 2. PMID 17909913
- BACKGROUNDSatoi S, Toyokawa H, Yanagimoto H, Yamamoto T, Yamao J, Kim S, Matsui Y, Takai S, Mergental H, Kamiyama Y; Department of Surgery, Kansai Medical University, Osaka, Japan. A new guideline to reduce postoperative morbidity after pancreaticoduodenectomy. Pancreas. 2008 Aug;37(2):128-33. doi: 10.1097/MPA.0b013e318162cb53.