Clinical trial · Interventional
Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma
Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
NCT01291927CI-TRIAL-00004396unknownN/AClinicalTrials.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)
The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Periampullary Carcinoma Nos | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreas-sparing duodenectomy | Procedure | — | UNRESOLVED |
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pancreas-sparing duodenectomy
- interventionNames
- Procedure: Pancreas-sparing duodenectomy
- type
- ACTIVE_COMPARATOR
- label
- Pancreaticoduodenectomy
- interventionNames
- Procedure: Pancreaticoduodenectomy
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 5 years
- description
- It is an average time peroid.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater) * Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0 * ASA score: \< 3 * Liver function:Child-Pugh A * No history of other cancers * No history of preoperative chemotherapy or radiotherapy * Written informed consent Exclusion Criteria: * There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma * Pre- and intra-operative stage: more advanced than T2,or with remote metastasis * The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy * The Patients received upper abdominal surgery * ASA score: ≥ 3 * Liver function:Child-Pugh B or C * Pregnancy patients
References
Publications (0)
Data not yet available
No reference posted for this study.