Robotic vs Open Pancreatoduodenectomy

NCT06981273 | Not Yet Recruiting

• 1 other identifier: SPAIN PD Trial
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic surgery, specifically pancreatoduodenectomy (PD), is a complex procedure often required for patients with pancreatic or other periampullary cancers. In recent years, minimally invasive techniques have become more popular, especially robotic-assisted surgery. However, there are limited studies comparing robotic surgery to traditional open surgery. This is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess complications within 90 days after surgery. This study is important because it will provide evidence on which approach is safer and more effective for patients. The study follows a \*\*prospective, randomized, and multicenter design\*\*, meaning patients are assigned to either robotic or open surgery randomly, and multiple hospitals are involved. The study will include all eligible patients undergoing planned PD surgery, either by robotic or open technique. To be included in the study, patients must meet these conditions:

• Be \*\*18 years or older\*\*.
• Require \*\*planned PD surgery\*\*.
• Sign an \*\*informed consent form\*\*. Who Cannot Participate? Patients will \*\*not\*\* be included if they:
• \*\*Refuse the procedure\*\*.
• Have \*\*uncertainty about vascular involvement\*\*.
• Have a severe health condition classified as \*\*ASA IV\*\* (high-risk for surgery). The main outcome measured will be the \*\*Comprehensive Complication Index (CCI), a standardized way to assess post-surgical complications. Additional factors being studied include:
• \*\*Clinical outcomes\*\* during and after surgery.
• \*\*Quality of life\*\* assessments.
• \*\*Surgical costs\*\*.
• \*\*Hospital stay duration\*\*.
• \*\*Need to switch from robotic to open surgery\*\*.
• \*\*Need for additional surgery (reoperations)\*\*.
• \*\*Hospital readmissions\*\*. Where Is the Study Being Conducted? The study is being conducted in \*\*ten major hospitals across Spain\*\*:
• Hospital del Mar, Barcelona
• Hospital Balmis, Alicante
• Hospital Vall d'Hebron, Barcelona
• Arnau de Vilanova, Lleida
• Joan XXIII, Tarragona
• Hospital Sant Pau, Barcelona
• Germans Trias i Pujol, Barcelona
• Hospital Clínic, Barcelona
• HM Sanchinarro, Madrid
• Hospital Rio Hortega, Valladolid

Conditions

Pancreas Neoplasms

Keywords

Robotic; pancreaticoduodenectony; Robotic surgery

Outcome Measures

Primary Outcomes (1)

• Complication Index

  Morbidity is assessed using the Complication Index (CCI) (www.assesssurgery.com). The primary objective is to measure CCI®, which tracks complications up to 90 days after surgery.

  up to 90 days after surgery

Secondary Outcomes (8)

• Cost effectiveness

  3 months after surgery

• Tumor clearance

  until the end of the study

• operative time

  during the surgery

• Blood loss

  during the surgery

• Conversion to open surgery

  during surgery

Study Arms (2)

Robotic

EXPERIMENTAL

Robotic pancreatoduodenectomy is performed under the robotic da Vinci system where at least the pancreatic and biliary anastomosis is performed throughout this approach.

Procedure: Robotic pancreatoduodenectomy

Open

ACTIVE COMPARATOR

open pancreatoduodenectomy is performed through a laparotomy following the standard criteria for this type of surgery.

Procedure: open pancreatoduodenectomy

Interventions

Robotic pancreatoduodenectomy PROCEDURE

A Robotic approach pancreatoduodenectomy is performed on patients

Robotic

open pancreatoduodenectomy PROCEDURE

An open approach for pancreatoduodenectomy is performed

Open

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Spain

Location

Related Publications (19)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Benedetto Ielpo, PhD, MD, FACS, FEBS

CONTACT

0034 932 48 30 00; bielpo@hmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: May 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)