Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

NCT04400357 | Completed DMC

• 1 other identifier: KY2020-93
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.

Conditions

Pancreatic Adenocarcinoma; Pancreatic Cysts; Pancreatic Endocrine Tumors; Chronic Pancreatitis; Cholangiocarcinoma, Extrahepatic; Ampullary Adenocarcinoma; Duodenal Adenocarcinoma

Keywords

pancreaticoduodenectomy; Whipple; robotic; daVinci; pancreatic cancer; outcomes; pancreatectomy; functional recovery; complications; recurrence; circulating tumor DNA; perioperative inflammation

Outcome Measures

Primary Outcomes (1)

• Time to functional recovery postoperatively

  Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following: * Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score) * Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired) * Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support * No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.

  From date of surgery to date of functional recovery as described, assessed up to 90 days.

Secondary Outcomes (11)

• Intraoperative blood loss

  During surgery

• Operative time

  During surgery

• Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively

  Postoperative Day 1 to Day 56

• Postoperative complication rates and associated interventions

  Postoperative Day 1 to Day 30

• Postoperative mortality

  Postoperative Day 1 to Day 90

Study Arms (2)

Robotic pancreaticoduodenectomy

EXPERIMENTAL

Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.

Procedure: Robotic pancreaticoduodenectomy

Open pancreaticoduodenectomy

ACTIVE COMPARATOR

Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy.

Procedure: Open pancreaticoduodenectomy

Interventions

Robotic pancreaticoduodenectomy PROCEDURE

Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.

Robotic pancreaticoduodenectomy

Open pancreaticoduodenectomy PROCEDURE

Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.

Open pancreaticoduodenectomy

Eligibility Criteria

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

You may qualify if:

• Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region
• Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease)
• Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver, CT chest, and Cancer Antigen 19-9 is also mandatory.

You may not qualify if:

• Body mass index \> 35 kg/m2
• Pregnancy
• Previous history of major abdominal surgery
• Requirement for multivisceral resection (additional surgical resection)
• Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma)
• Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature

Sponsors & Collaborators

• Ruijin Hospital: lead
• Intuitive Surgical: collaborator

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (10)

• Nassour I, Winters SB, Hoehn R, Tohme S, Adam MA, Bartlett DL, Lee KK, Paniccia A, Zureikat AH. Long-term oncologic outcomes of robotic and open pancreatectomy in a national cohort of pancreatic adenocarcinoma. J Surg Oncol. 2020 Aug;122(2):234-242. doi: 10.1002/jso.25958. Epub 2020 Apr 29.

  PMID: 32350882 BACKGROUND

• Shi Y, Jin J, Qiu W, Weng Y, Wang J, Zhao S, Huo Z, Qin K, Wang Y, Chen H, Deng X, Peng C, Shen B. Short-term Outcomes After Robot-Assisted vs Open Pancreaticoduodenectomy After the Learning Curve. JAMA Surg. 2020 May 1;155(5):389-394. doi: 10.1001/jamasurg.2020.0021.

  PMID: 32129815 BACKGROUND

• Podda M, Gerardi C, Di Saverio S, Marino MV, Davies RJ, Pellino G, Pisanu A. Robotic-assisted versus open pancreaticoduodenectomy for patients with benign and malignant periampullary disease: a systematic review and meta-analysis of short-term outcomes. Surg Endosc. 2020 Jun;34(6):2390-2409. doi: 10.1007/s00464-020-07460-4. Epub 2020 Feb 18.

  PMID: 32072286 BACKGROUND

• Zureikat AH, Beane JD, Zenati MS, Al Abbas AI, Boone BA, Moser AJ, Bartlett DL, Hogg ME, Zeh HJ 3rd. 500 Minimally Invasive Robotic Pancreatoduodenectomies: One Decade of Optimizing Performance. Ann Surg. 2021 May 1;273(5):966-972. doi: 10.1097/SLA.0000000000003550.

  PMID: 31851003 BACKGROUND

• Girgis MD, Zenati MS, King JC, Hamad A, Zureikat AH, Zeh HJ, Hogg ME. Oncologic Outcomes After Robotic Pancreatic Resections Are Not Inferior to Open Surgery. Ann Surg. 2021 Sep 1;274(3):e262-e268. doi: 10.1097/SLA.0000000000003615.

  PMID: 31663967 BACKGROUND

• Shi Y, Wang W, Qiu W, Zhao S, Wang J, Weng Y, Huo Z, Jin J, Wang Y, Deng X, Shen B, Peng C. Learning Curve From 450 Cases of Robot-Assisted Pancreaticoduocectomy in a High-Volume Pancreatic Center: Optimization of Operative Procedure and a Retrospective Study. Ann Surg. 2021 Dec 1;274(6):e1277-e1283. doi: 10.1097/SLA.0000000000003664.

  PMID: 31651533 BACKGROUND

• Zhao W, Liu C, Li S, Geng D, Feng Y, Sun M. Safety and efficacy for robot-assisted versus open pancreaticoduodenectomy and distal pancreatectomy: A systematic review and meta-analysis. Surg Oncol. 2018 Sep;27(3):468-478. doi: 10.1016/j.suronc.2018.06.001. Epub 2018 Jun 4.

  PMID: 30217304 BACKGROUND

• McMillan MT, Zureikat AH, Hogg ME, Kowalsky SJ, Zeh HJ, Sprys MH, Vollmer CM Jr. A Propensity Score-Matched Analysis of Robotic vs Open Pancreatoduodenectomy on Incidence of Pancreatic Fistula. JAMA Surg. 2017 Apr 1;152(4):327-335. doi: 10.1001/jamasurg.2016.4755.

  PMID: 28030724 BACKGROUND

• Zureikat AH, Postlewait LM, Liu Y, Gillespie TW, Weber SM, Abbott DE, Ahmad SA, Maithel SK, Hogg ME, Zenati M, Cho CS, Salem A, Xia B, Steve J, Nguyen TK, Keshava HB, Chalikonda S, Walsh RM, Talamonti MS, Stocker SJ, Bentrem DJ, Lumpkin S, Kim HJ, Zeh HJ 3rd, Kooby DA. A Multi-institutional Comparison of Perioperative Outcomes of Robotic and Open Pancreaticoduodenectomy. Ann Surg. 2016 Oct;264(4):640-9. doi: 10.1097/SLA.0000000000001869.

  PMID: 27433907 BACKGROUND

• Jin J, Shi Y, Chen M, Qian J, Qin K, Wang Z, Chen W, Jin W, Lu F, Li Z, Wu Z, Jian L, Han B, Liang X, Sun C, Wu Z, Mou Y, Yin X, Huang H, Chen H, Gemenetzis G, Deng X, Peng C, Shen B. Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial. Trials. 2021 Dec 27;22(1):954. doi: 10.1186/s13063-021-05939-6.

  PMID: 34961558 DERIVED

MeSH Terms

Conditions

Pancreatic Cyst; Pancreatitis, Chronic; Cholangiocarcinoma; Pancreatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Baiyong Shen, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

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: Attending Surgeon, Pancreatic Disease Center

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 22, 2020
• Study Start: September 28, 2020
• Primary Completion: November 28, 2024
• Study Completion: February 28, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)