Clinical trial · Interventional
Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
- 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)
The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| duct-to-mucosa | Procedure | — | UNRESOLVED |
| Internal stent | Device | — | UNRESOLVED |
| invagination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- duct-to-mucosa
- description
- duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
- interventionNames
- Procedure: duct-to-mucosa
- Device: Internal stent
- type
- ACTIVE_COMPARATOR
- label
- invagination
- description
- invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
- interventionNames
- Procedure: invagination
- Device: Internal stent
Primary outcomes (1)
- measure
- pancreatic fistula
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy * 18 to 80 y/o * Operation-tolerated * Informed consent Exclusion Criteria: * History of gastrointestinal operation * Pancreaticoduodenectomy is given up during operation * Pancreatic duct is difficult to locate * Patients require to exit from the study anytime
References
Publications (1)
- DERIVEDBai X, Zhang Q, Gao S, Lou J, Li G, Zhang Y, Ma T, Zhang Y, Xu Y, Liang T. Duct-to-Mucosa vs Invagination for Pancreaticojejunostomy after Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial from a Single Surgeon. J Am Coll Surg. 2016 Jan;222(1):10-8. doi: 10.1016/j.jamcollsurg.2015.10.003. Epub 2015 Oct 21. PMID 26577499