Clinical trial · Interventional
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)
A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions
NCT02081131CI-TRIAL-00019123PLOTcompletedN/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 aim of this study is to compare the two surgical approaches namely laparoscopic pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and pancreatic head cancers in terms of parameters like hospital stay, pathological radicality, complication rate, peri-operative and post operative outcomes.
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 |
|---|---|---|---|
| Adenocarcinoma of Head of Pancreas | — | UNRESOLVED | — |
| Carcinoma of Ampulla of Vater | Ampulla of Vater Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangio Carcinoma | — | UNRESOLVED | — |
| Duodenal Adenocarcinoma | Duodenal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
| Open surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic Surgery
- description
- patients will be randomized to laparoscopic pancreatoduodenectomy group
- interventionNames
- Procedure: Laparoscopic surgery
- type
- ACTIVE_COMPARATOR
- label
- Open Surgery
- description
- Patients will be randomized to Open pancreatoduodenectomy
- interventionNames
- Procedure: Open surgery
Primary outcomes (1)
- measure
- Hospital Stay
- timeFrame
- discharge from hospital or death which ever earlier recorded over 100 days from date of admission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Adult males or females with a diagnosis of either of resectable Periampullary and pancreatic head cancers with 1. No evidence of metastasis 2. Radiological non-involvement of Superior Mesenteric Vein \& Portal Vein 3. Preserved fat planes between celiac axis, Hepatic Artery \& Superior Mesenteric Artery Exclusion Criteria: 1. Unresectable Tumor at surgery 2. Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass 3. With prior Neoadjuvant treatment
References
Publications (4)
- BACKGROUNDAsbun HJ, Stauffer JA. Laparoscopic vs open pancreaticoduodenectomy: overall outcomes and severity of complications using the Accordion Severity Grading System. J Am Coll Surg. 2012 Dec;215(6):810-9. doi: 10.1016/j.jamcollsurg.2012.08.006. Epub 2012 Sep 19. PMID 22999327
- BACKGROUNDPalanivelu C, Rajan PS, Rangarajan M, Vaithiswaran V, Senthilnathan P, Parthasarathi R, Praveen Raj P. Evolution in techniques of laparoscopic pancreaticoduodenectomy: a decade long experience from a tertiary center. J Hepatobiliary Pancreat Surg. 2009;16(6):731-40. doi: 10.1007/s00534-009-0157-8. Epub 2009 Aug 4. PMID 19652900
- BACKGROUNDKim SC, Song KB, Jung YS, Kim YH, Park DH, Lee SS, Seo DW, Lee SK, Kim MH, Park KM, Lee YJ. Short-term clinical outcomes for 100 consecutive cases of laparoscopic pylorus-preserving pancreatoduodenectomy: improvement with surgical experience. Surg Endosc. 2013 Jan;27(1):95-103. doi: 10.1007/s00464-012-2427-9. Epub 2012 Jun 30. PMID 22752284
- DERIVEDPalanivelu C, Senthilnathan P, Sabnis SC, Babu NS, Srivatsan Gurumurthy S, Anand Vijai N, Nalankilli VP, Praveen Raj P, Parthasarathy R, Rajapandian S. Randomized clinical trial of laparoscopic versus open pancreatoduodenectomy for periampullary tumours. Br J Surg. 2017 Oct;104(11):1443-1450. doi: 10.1002/bjs.10662. PMID 28895142