Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Exposure, Repair or Reconstruction

NCT06024343 | Completed DMC

• 1 other identifier: CSPAC-MIEN-1
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of concomitant main pancreatic duct exposure, repair, or reconstruction during minimally invasive pancreatic tumor enucleation on long-term patient prognosis and quality of life.

Conditions

Pancreatic Tumor, Benign; Pancreatic Neuroendocrine Tumor; Solid Pseudopapillary Tumor of the Pancreas

Keywords

Pancreatic benign or low-grade malignant tumors; Minimally invasive enucleation; Main Pancreatic Duct Repair or Reconstruction; Long-term prognosis; Quality of life

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinically Relevant Postoperative Pancreatic Fistula

  Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.

  Within 90 days after surgery.

Secondary Outcomes (9)

• Perioperative complication rate according to the Clavien-Dindo classification

  Within 90 days after surgery.

• Postoperative pancreatic hemorrhage (PPH) rate

  Within 90 days after surgery.

• Delayed gastric emptying (DGE) rate

  Within 90 days after surgery.

• Reoperation rate

  Within 90 days after surgery.

• Rate of pancreatic enzyme-dependent malabsorption

  Through study completion, an average of 3 year.

Study Arms (2)

MPD Manipulation

EXPERIMENTAL

During laparoscopic or robotic pancreatic tumor enucleation, tumors located near or surrounding the main pancreatic duct (MPD) can result in the exposure, injury, or transection of the MPD, requiring MPD repair and reconstruction.

Procedure: MPD Exposure, Repair or Reconstruction

MPD not exposed

NO INTERVENTION

In laparoscopic or robotic pancreatic tumor enucleation procedures where the MPD remains unexposed, there is no need for MPD repair and reconstruction.

Interventions

MPD Exposure, Repair or Reconstruction PROCEDURE

During laparoscopic or robotic pancreatic tumor enucleation, if the main pancreatic duct (MPD) is injured due to its proximity or encasement by the tumor, MPD manipulation is performed. MPD manipulation is categorized into three scenarios: exposed but not injured; simple suture repair (using 5-0/6-0 PROLENE polypropylene suture); and suture repair/reconstruction following stent insertion. Using the F6 ventricular drainage catheter with 1-2 side holes trimmed as the stent, typically requiring 10 cm for passage through the duodenal papilla and 3-4 cm if not passing through. Following stent placement, intermittent suturing reconstructs the MPD, with one stitch securing the stent by passing through both the stent side wall and the MPD.

MPD Manipulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years, regardless of gender;
• patients with solitary benign or low-grade malignant pancreatic tumors, including NET, SPN, and cystic tumors;
• eligible for pancreatic parenchyma-sparing resection (PSR) according to contemporary guidelines;
• patients with an ECOG performance status of 0 or 1;
• successfully received MIEN (laparoscopic or robotic)

You may not qualify if:

• body mass index \> 35 kg/m2;
• concomitant malignancies;
• intraoperative frozen section or postoperative pathology indicating malignancy, requiring conversion to oncologic resection;
• loss to follow-up within 90 days postoperatively.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (14)

• Cauley CE, Pitt HA, Ziegler KM, Nakeeb A, Schmidt CM, Zyromski NJ, House MG, Lillemoe KD. Pancreatic enucleation: improved outcomes compared to resection. J Gastrointest Surg. 2012 Jul;16(7):1347-53. doi: 10.1007/s11605-012-1893-7. Epub 2012 Apr 24.

  PMID: 22528577 BACKGROUND

• Giuliani T, De Pastena M, Paiella S, Marchegiani G, Landoni L, Festini M, Ramera M, Marinelli V, Casetti L, Esposito A, Bassi C, Salvia R. Pancreatic Enucleation Patients Share the Same Quality of Life as the General Population at Long-Term Follow-Up: A Propensity Score-Matched Analysis. Ann Surg. 2023 Mar 1;277(3):e609-e616. doi: 10.1097/SLA.0000000000004911. Epub 2021 Apr 14.

  PMID: 33856383 BACKGROUND

• Kromrey ML, Bulow R, Hubner J, Paperlein C, Lerch MM, Ittermann T, Volzke H, Mayerle J, Kuhn JP. Prospective study on the incidence, prevalence and 5-year pancreatic-related mortality of pancreatic cysts in a population-based study. Gut. 2018 Jan;67(1):138-145. doi: 10.1136/gutjnl-2016-313127. Epub 2017 Sep 6.

  PMID: 28877981 BACKGROUND

• van Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16.

  PMID: 31527862 BACKGROUND

• Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.

  PMID: 28448665 BACKGROUND

• Zhou Y, Zhao M, Wu L, Ye F, Si X. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment. Pancreatology. 2016 Nov-Dec;16(6):1092-1098. doi: 10.1016/j.pan.2016.07.006. Epub 2016 Jul 9.

  PMID: 27423534 BACKGROUND

• Guerra F, Giuliani G, Bencini L, Bianchi PP, Coratti A. Minimally invasive versus open pancreatic enucleation. Systematic review and meta-analysis of surgical outcomes. J Surg Oncol. 2018 Jun;117(7):1509-1516. doi: 10.1002/jso.25026. Epub 2018 Mar 25.

  PMID: 29574729 BACKGROUND

• Dalla Valle R, Cremaschi E, Lamecchi L, Guerini F, Rosso E, Iaria M. Open and minimally invasive pancreatic neoplasms enucleation: a systematic review. Surg Endosc. 2019 Oct;33(10):3192-3199. doi: 10.1007/s00464-019-06967-9. Epub 2019 Jul 30.

  PMID: 31363894 BACKGROUND

• Shukla PJ, Barreto SG, Shrikhande SV. Enucleation of pancreatic neoplasms (Br J Surg 2007; 94: 1254-1259). Br J Surg. 2008 Feb;95(2):261; author reply 261-2. doi: 10.1002/bjs.6148. No abstract available.

  PMID: 18196559 BACKGROUND

• Brient C, Regenet N, Sulpice L, Brunaud L, Mucci-Hennekine S, Carrere N, Milin J, Ayav A, Pradere B, Hamy A, Bresler L, Meunier B, Mirallie E. Risk factors for postoperative pancreatic fistulization subsequent to enucleation. J Gastrointest Surg. 2012 Oct;16(10):1883-7. doi: 10.1007/s11605-012-1971-x. Epub 2012 Aug 8.

  PMID: 22872510 BACKGROUND

• Bartolini I, Bencini L, Bernini M, Farsi M, Calistri M, Annecchiarico M, Moraldi L, Coratti A. Robotic enucleations of pancreatic benign or low-grade malignant tumors: preliminary results and comparison with robotic demolitive resections. Surg Endosc. 2019 Sep;33(9):2834-2842. doi: 10.1007/s00464-018-6576-3. Epub 2018 Nov 12.

  PMID: 30421079 BACKGROUND

• Ei S, Mihaljevic AL, Kulu Y, Kaiser J, Hinz U, Buchler MW, Hackert T. Enucleation for benign or borderline tumors of the pancreas: comparing open and minimally invasive surgery. HPB (Oxford). 2021 Jun;23(6):921-926. doi: 10.1016/j.hpb.2020.10.001. Epub 2020 Oct 18.

  PMID: 33087306 BACKGROUND

• Zhang RC, Zhou YC, Mou YP, Huang CJ, Jin WW, Yan JF, Wang YX, Liao Y. Laparoscopic versus open enucleation for pancreatic neoplasms: clinical outcomes and pancreatic function analysis. Surg Endosc. 2016 Jul;30(7):2657-65. doi: 10.1007/s00464-015-4538-6. Epub 2015 Oct 20.

  PMID: 26487211 BACKGROUND

• Strobel O, Cherrez A, Hinz U, Mayer P, Kaiser J, Fritz S, Schneider L, Klauss M, Buchler MW, Hackert T. Risk of pancreatic fistula after enucleation of pancreatic tumours. Br J Surg. 2015 Sep;102(10):1258-66. doi: 10.1002/bjs.9843. Epub 2015 Jun 24.

  PMID: 26109380 BACKGROUND

Related Links

• In 2021, Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery for the first time and outlined four main surgical approaches.

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenoma, Islet Cell

Interventions

Wound Healing; Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena; Surgical Procedures, Operative

Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaowu Xu, MD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 6, 2023
• Study Start: July 1, 2019
• Primary Completion: May 30, 2024
• Study Completion: August 31, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)