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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Robotic versus open pancreatoduodenectomy for pancreatic tumors

Official title: SPAIN Trial Comparing Open vs Robotic Pancreatoduodenectomy

Run by Hospital del Mar · NCT06981273 · Data updated 2026-11-12

This study tests whether robotic pancreatoduodenectomy can reduce complications within 90 days compared to open surgery for patients needing a Whipple procedure.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorHospital del Mar
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Barcelona)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedSeptember 1, 2027
Study endsSeptember 1, 2027
Registry record updatedJuly 8, 2026
Trial IDNCT06981273 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older undergoing planned pancreatoduodenectomy (robotic or open) and able to give informed consent.

Probably not a fit

Patients with poor general health (ASA IV), pancreatitis, or unclear vascular involvement may not benefit and could be excluded or receive alternative management.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This national, multicenter randomized trial in Spain compares robotic-assisted pancreatoduodenectomy (R-PDR) to the traditional open pancreatoduodenectomy (PDA) for patients with pancreatic or periampullary cancers. The primary outcome is postoperative morbidity within 90 days, measured by the Complication Index (CCI). Secondary outcomes include intraoperative factors like blood loss and operative time, conversion rates, and oncologic outcomes when applicable. Eligible participants are adults undergoing planned pancreatoduodenectomy without prohibitive comorbidity, and the study is conducted across multiple centers led by Hospital del Mar. The trial aims to provide high-quality evidence on safety and effectiveness of robotic versus open approaches in this complex surgery.

Why it matters

Potential benefit: If successful, patients may experience lower complication rates and faster recovery with robotic surgery compared to open surgery.

How similar studies have gone: Prior data are limited; this trial seeks to provide robust evidence where previous studies have been small or observational.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18 years or older.
* Patients requiring planned pancreatoduodenectomy (robotic or open).
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Patients who refuse the procedure.
* Uncertainty about vascular involvement that could affect resectability.
* Poor general health status (American Society of Anesthesiologists \[ASA\] classification IV).
* Pancreatitis

Where it's running

  • Hospital del Mar
    Barcelona, Spain     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.