Pancreatic Tumor, BenignNCT06024343
Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Exposure, Repair or Reconstruction
A study testing MPD Exposure, Repair or Reconstruction in people with Pancreatic Tumor, Benign and Pancreatic Neuroendocrine Tumor, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- What is being tested?
- MPD Exposure, Repair or Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: Long-term Outcome in Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Exposure, Repair or Reconstruction: A Prospective Cohort Study
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.
Read the detailed description
Standard surgical procedures for benign or low-grade malignant pancreatic tumors is associated with increased risks of postoperative complications and long-term pancreatic functional impairment, while parenchyma-sparing pancreatectomy such as enucleation can reduce the incidence of complications and preserve healthy parenchyma, thereby preserve both endocrine and exocrine pancreatic function. It has been reported that pancreatic tumor enucleation is a safe and feasible approach in preserving normal physiological function in patients undergoing pancreatic surgery.
With the growing emphasis on routine screenings and the application of high-quality thin-slice imaging techniques, the detection rates of pancreatic tumors have witnessed a steady increase. Additionally, there is a notable trend towards younger patients being diagnosed with pancreatic tumors. Consequently, in conjunction with ensuring safe and thorough tumor resection while maximizing preservation of pancreatic function, there is a current clinical demand to further reduce surgical trauma.
Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation procedures offer well-known advantages associated with minimally invasive approaches, such as shorter postoperative hospital stays and lower overall complication rates. While the occurrence rate of severe complications, such as postoperative hemorrhage, remains relatively low, the development of postoperative pancreatic fistula (POPF) continues to pose a challenging issue.
The distance between the tumor and the main pancreatic duct (MPD) is considered a crucial factor influencing the occurrence of POPF after enucleation. However, these data have been rarely described in previous studies, making it challenging to accurately assess their actual impact on the rate of POPF occurrence. Heeger et al. suggested that the risk of POPF increases with closer proximity of the tumor to the MPD. The incidence of POPF was higher in deep-seated tumors after pancreatic enucleation (distance to MPD <3 mm) compared to superficial tumors (>3 mm) (73.3% vs. 30.0%, P=0.002). Other studies have even limited this critical distance to 2mm. Some research has indicated that if the tumor invades or encases the MPD, enucleation surgery should be contraindicated, and standard resection should be preferred to avoid the risk of POPF postoperatively. However, a retrospective analysis by Strobel et al. on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in close proximity to the MPD can be safely resected, although their study did not include cases with tumor encasement of the MPD.
During the expansive growth of solid tumors such as neuroendocrine tumors and solid pseudopapillary neoplasms, they can compress the MPD, causing inflammatory adhesions. Cystic tumors can also surround the MPD as they grow. Enucleation of these tumors may inevitably lead to exposure, injury, or transection of the MPD, necessitating repair and reconstruction. Recent years have seen successful cases reported of end-to-end anastomosis of the MPD. Minimally invasive techniques have also facilitated the promotion of MPD repair or bridging reconstruction surgeries. However, there remains a lack of comprehensive research data in this field.
The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures involving MPD exposure, repair, or reconstruction, the control of POPF, and the long-term prognosis and quality of life of patients after MPD repair or reconstruction remain unclear. Therefore, this study aims to conduct a prospective cohort study. The results of this study will serve as a valuable reference for clinical practice and promote the development and application of minimally invasive pancreatic tumor enucleation procedures.
- Conditions
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- Being tested
- MPD Exposure, Repair or Reconstruction
- Keywords
- Pancreatic benign or low-grade malignant tumors, Minimally invasive enucleation, Main Pancreatic Duct Repair or Reconstruction, Long-term prognosis, Quality of life
- Medical subject headings
- Pancreatic Neoplasms, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPD Exposure, Repair or ReconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days after surgery.
Secondary outcomes (9)
Perioperative complication rate according to the Clavien-Dindo classification
Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.
Measured: Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate
Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.
Measured: Within 90 days after surgery.
Delayed gastric emptying (DGE) rate
Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.
Measured: Within 90 days after surgery.
Reoperation rate
Reoperation rate within 90 days after surgery.
Measured: Within 90 days after surgery.
Rate of pancreatic enzyme-dependent malabsorption
Postoperative pancreatic enzyme-dependent malabsorption rate.
Measured: Through study completion, an average of 3 year.
Rate of new-onset diabetes
Postoperative new-onset diabetes rate.
Measured: Through study completion, an average of 3 year.
Life quality satisfaction evaluated according to EORTC C30 scale
The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.
Measured: Through study completion, an average of 3 year.
R0 resection rate
R0 margin rate on postoperative pathological assessment.
Measured: From the date of surgery to 1 month after surgery.
Recurrence-free survival (RFS)
The time of surgery to the time of tumor recurrence or death.
Measured: Through study completion, an average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Jul 2019
- Primary completion30 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Tumor, BenignStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Fudan UniversityXiaowu Xu, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024343
- Sponsor's protocol ID
- CSPAC-MIEN-1
- Status last verified
- Nov 2024
- First submitted
- 23 Aug 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22528577Giuliani 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.
PubMed 33856383Kromrey 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.
PubMed 28877981van 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.
PubMed 31527862Dasari 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.
PubMed 28448665Zhou 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.
PubMed 27423534Guerra 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.
PubMed 29574729Dalla 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.
PubMed 31363894Shukla 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.
PubMed 18196559Brient 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.
PubMed 22872510Bartolini 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.
PubMed 30421079Ei 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.
PubMed 33087306Zhang 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.
PubMed 26487211Strobel 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.
PubMed 26109380
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome in Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Exposure, Repair or Reconstruction: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06024343
- Acronym / sponsor ID
- CSPAC-MIEN-1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Standard surgical procedures for benign or low-grade malignant pancreatic tumors is associated with increased risks of postoperative complications and long-term pancreatic functional impairment, while parenchyma-sparing pancreatectomy such as enucleation can reduce the incidence of complications and preserve healthy parenchyma, thereby preserve both endocrine and exocrine pancreatic function. It has been reported that pancreatic tumor enucleation is a safe and feasible approach in preserving normal physiological function in patients undergoing pancreatic surgery.
With the growing emphasis on routine screenings and the application of high-quality thin-slice imaging techniques, the detection rates of pancreatic tumors have witnessed a steady increase. Additionally, there is a notable trend towards younger patients being diagnosed with pancreatic tumors. Consequently, in conjunction with ensuring safe and thorough tumor resection while maximizing preservation of pancreatic function, there is a current clinical demand to further reduce surgical trauma.
Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation procedures offer well-known advantages associated with minimally invasive approaches, such as shorter postoperative hospital stays and lower overall complication rates. While the occurrence rate of severe complications, such as postoperative hemorrhage, remains relatively low, the development of postoperative pancreatic fistula (POPF) continues to pose a challenging issue.
The distance between the tumor and the main pancreatic duct (MPD) is considered a crucial factor influencing the occurrence of POPF after enucleation. However, these data have been rarely described in previous studies, making it challenging to accurately assess their actual impact on the rate of POPF occurrence. Heeger et al. suggested that the risk of POPF increases with closer proximity of the tumor to the MPD. The incidence of POPF was higher in deep-seated tumors after pancreatic enucleation (distance to MPD <3 mm) compared to superficial tumors (>3 mm) (73.3% vs. 30.0%, P=0.002). Other studies have even limited this critical distance to 2mm. Some research has indicated that if the tumor invades or encases the MPD, enucleation surgery should be contraindicated, and standard resection should be preferred to avoid the risk of POPF postoperatively. However, a retrospective analysis by Strobel et al. on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in close proximity to the MPD can be safely resected, although their study did not include cases with tumor encasement of the MPD.
During the expansive growth of solid tumors such as neuroendocrine tumors and solid pseudopapillary neoplasms, they can compress the MPD, causing inflammatory adhesions. Cystic tumors can also surround the MPD as they grow. Enucleation of these tumors may inevitably lead to exposure, injury, or transection of the MPD, necessitating repair and reconstruction. Recent years have seen successful cases reported of end-to-end anastomosis of the MPD. Minimally invasive techniques have also facilitated the promotion of MPD repair or bridging reconstruction surgeries. However, there remains a lack of comprehensive research data in this field.
The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures involving MPD exposure, repair, or reconstruction, the control of POPF, and the long-term prognosis and quality of life of patients after MPD repair or reconstruction remain unclear. Therefore, this study aims to conduct a prospective cohort study. The results of this study will serve as a valuable reference for clinical practice and promote the development and application of minimally invasive pancreatic tumor enucleation procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPD Manipulation | Experimental | Procedure: MPD Exposure, Repair or ReconstructionDuring 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPD Exposure, Repair or ReconstructionDuring 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. | Procedure or surgery | MPD Manipulation |
Primary outcome
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Time frame: Within 90 days after surgery.
Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
9 secondary outcomes
Perioperative complication rate according to the Clavien-Dindo classification
Time frame: Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate
Time frame: Within 90 days after surgery.
Delayed gastric emptying (DGE) rate
Time frame: Within 90 days after surgery.
Reoperation rate
Time frame: Within 90 days after surgery.
Rate of pancreatic enzyme-dependent malabsorption
Time frame: Through study completion, an average of 3 year.
Rate of new-onset diabetes
Time frame: Through study completion, an average of 3 year.
Life quality satisfaction evaluated according to EORTC C30 scale
Time frame: Through study completion, an average of 3 year.
R0 resection rate
Time frame: From the date of surgery to 1 month after surgery.
Recurrence-free survival (RFS)
Time frame: Through study completion, an average of 3 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 22528577Cauley 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.
- Background: PubMed 33856383Giuliani 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.
- Background: PubMed 28877981Kromrey 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.
- Background: PubMed 31527862van 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.
- Background: PubMed 28448665Dasari 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.
- Background: PubMed 27423534Zhou 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.
- Background: PubMed 29574729Guerra 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.
- Background: PubMed 31363894Dalla 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.
- Background: PubMed 18196559Shukla 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.
- Background: PubMed 22872510Brient 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.
- Background: PubMed 30421079Bartolini 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.
- Background: PubMed 33087306Ei 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.
- In 2021, Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery for the first time and outlined four main surgical approaches.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianjun Yu, MD, PhD principal investigator
Fudan University
Xiaowu Xu, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPD Exposure, Repair or Reconstruction in people with Pancreatic Tumor, Benign and Pancreatic Neuroendocrine Tumor, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Relevant Postoperative Pancreatic Fistula (time frame: Within 90 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024343, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.