Robotic versus open pancreatoduodenectomy (SPAIN Trial): protocol for a multicenter randomized controlled trial assessing safety, efficacy and cost-effectiveness.

Alberto Carrancho, Danilo Vinci, Fernando Burdio, Patricia Sànchez-Velázquez, Benedetto Ielpo, SPAIN Trial group

Registry-linked trialAbstract readClinical Trial Protocol

In one paragraph

Article in Updates in surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06981273 (SPAIN Trial Comparing Open vs Robotic Pancreatoduodenectomy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06981273 narecruitingnot on this map

SPAIN Trial Comparing Open vs Robotic Pancreatoduodenectomy

TypeinterventionalSponsorHospital del MarRan2025 to 2027Enrolled120ConditionsPancreas NeoplasmsArmsRobotic pancreatoduodenectomy, open pancreatoduodenectomy

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Alberto Carrancho *Hepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Pompeu Fabra University, Passeig Maritim 25, Barcelona, 08034, Spain.

Danilo Vinci *Hepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Pompeu Fabra University, Passeig Maritim 25, Barcelona, 08034, Spain.

Fernando BurdioHepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Pompeu Fabra University, Passeig Maritim 25, Barcelona, 08034, Spain.

Patricia Sànchez-VelázquezHepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Pompeu Fabra University, Passeig Maritim 25, Barcelona, 08034, Spain.

Benedetto IelpoHepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Pompeu Fabra University, Passeig Maritim 25, Barcelona, 08034, Spain. ielpo.b@gmail.com.ORCID http://orcid.org/0000-0003-3129-3208

SPAIN Trial group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Minimally invasive pancreatoduodenectomy (PD), particularly through a robotic approach (RPD), is gaining increasing worldwide acceptance. However, high-quality evidence remains limited and very few randomized controlled trials have directly compared RPD with open PD (OPD). The SPAIN Trial (Spanish Pancreatoduodenectomy: Open vs. Robotic Approach) is designed to generate national evidence on the safety, efficacy, and economic value of RPD compared with the open technique. This is a national, multicentre, randomized, prospective, non-inferiority trial comparing RPD and OPD in high-volume Spanish centres with established robotic pancreatic programs. Adult patients indicated for elective PD due to benign or malignant disease of the pancreatic head, distal bile duct, duodenum, or ampulla of Vater will be randomized in a 2:1 ratio (2RPD:1OPD). The primary endpoint is overall postoperative morbidity within 90 days, assessed by the Comprehensive Complication Index (CCI). Secondary endpoints include intraoperative outcomes (operative time, blood loss, conversion rate), ISGPS-defined pancreatic complications, oncological outcomes (R0 resection, lymph node yield, time to adjuvant therapy), length of stay, readmission rates, and patient-reported quality of life using EQ-5D-5 L, EORTC QLQ-C30, and PAN-26 questionnaires. Cost-effectiveness will be assessed using Quality-Adjusted Life Years (QALYs) and Incremental Cost-Effectiveness Ratios (ICERs) from a healthcare perspective.Trial registration: ClinicalTrials.gov Identifier NCT06981273.

Indexed as

Cost-Benefit AnalysisCost-Effectiveness AnalysisPancreaticoduodenectomyRandomized Controlled Trials as TopicRobotic Surgical ProceduresEquivalence Trials as TopicHumansMulticenter Studies as TopicPostoperative ComplicationsProspective StudiesSpainTreatment OutcomeCost-effectivenessPancreatoduodenectomyRobotic

Identifiers

PMID42262715

DOI10.1007/s13304-026-02574-1

PMCPMC13538230

What OpenQuestion holds

Textmetadata

Read underepoch 390

Registered trials

NCT06981273ClinicalTrials.gov

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.