A Prospective Cohort Study on Ligation of Pancreatic Stump After Distal Pancreatectomy

Official title

A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy

Overview

The goal of this clinical trial is to learn if igation of pancreatic stump with quantified force works in decrease postoperative pancreatic fistula following distal pancreatectomy. The main outcome measures are: Postoperative pancreatic fistula; Postoperative hospital stay. Researchers will compare ligation to other pancreatic stump closure techniques to see if it decrease postoperative pancreatic fistula and postoperative hospital stay following distal pancreatectomy.

Detailed description

Introduction The closure of pancreatic stump after distal pancreatectomy remains controversial. Currently, the main methods of pancreatic stump closure include manual suturing and stapler closure. However, both methods carry a high risk of pancreatic fistula, which may be associated with the difficulty of balancing the provision of sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. Through in vitro experiments, we demonstrated that applying quantified ligation forces to pancreatic stumps can provide a pancreatic duct burst pressure of approximately 50-70 mmHg. This burst pressure is higher than the upper limit of normal pancreatic duct pressure and lower than the normal mean arterial pressure, theoretically balancing the pancreatic duct burst pressure and stump blood supply. Therefore, we designed this prospective cohort study to verify the above hypothesis.

Methods and analysis This is a prospective cohort study at single centre in China. The major eligibility criterion is the presence of lesions planned for distal pancreatectomy. The texture of the pancreas was determined by the surgeon and the first assistant during the operation as soft, medium, or hard. After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force. Postoperative regular follow-up will be performed. The primary outcomes included pancreatic fistula and postoperative hospital stay, and the secondary outcomes included intra-abdominal infection, incision infection, and postoperative treatment costs. The primary outcomes and secondary outcomes of patients in this cohort will be statistically compared with historical data using appropriate tests.

Ethics and dissemination The study has been approved by the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology(2024-0833-02). The results of the study will be published in an international peer-reviewed journal.

Interventions

• Other ligation of pancreatic stump with a quantified force
  After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
• Other Manual suturing or stapling closure.
  Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).

Primary outcome measures

• Pancreatic fistula [Time frame: Up to half a year from enrollment]
• Postoperative hospital stay [Time frame: Up to half a year from enrollment]

Secondary outcome measures (3)

• Intra-abdominal infection [Time frame: Up to half a year from enrollment]
• Incision infection [Time frame: Up to half a year from enrollment]
• Postoperative treatment costs [Time frame: Up to half a year from enrollment]

Eligibility criteria

Inclusion criteria

• Patients fully understand this study, voluntarily participate, and sign the Informed Consent Form (ICF);
• Age between 18 and 75 years old;
• Planned for distal pancreatectomy (including body and tail of the pancreas);
• The intended pancreatic transection line is located on the left side of the portal vein.

Exclusion criteria

• History of previous pancreatic surgery;
• Additional surgical procedures required for the residual pancreas;
• Proximal pancreatic duct obstruction, with planned anastomosis between the residual pancreas and the digestive tract;
• Use of long-acting somatostatin analogues during the perioperative period;
• Patients who are judged by the investigator to be unsuitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Uion Hospital, Tongji Medical College, HUST — Wuhan

Publications

• Kaneda Y, Kimura Y, Saito A, Ae R, Kawahira H, Sata N. Pancreas Ligation Device for Distal Pancreatectomy: An Ex Vivo Follow-Up Porcine Study. Cureus. 2023 Sep 6;15(9):e44771. doi: 10.7759/cureus.44771. eCollection 2023 Sep. PMID 37692176
• Funamizu N, Sogabe K, Shine M, Honjo M, Sakamoto A, Nishi Y, Matsui T, Uraoka M, Nagaoka T, Iwata M, Ito C, Tamura K, Sakamoto K, Ogawa K, Takada Y. Association between the Preoperative C-Reactive Protein-to-Albumin Ratio and the Risk for Postoperative Pancreatic Fistula following Distal Pancreatectomy for Pancreatic Cancer. Nutrients. 2022 Dec 10;14(24):5277. doi: 10.3390/nu14245277. PMID 36558435
• Mungroop TH, van der Heijde N, Busch OR, de Hingh IH, Scheepers JJ, Dijkgraaf MG, Groot Koerkamp B, Besselink MG, van Eijck CH. Randomized clinical trial and meta-analysis of the impact of a fibrin sealant patch on pancreatic fistula after distal pancreatectomy: CPR trial. BJS Open. 2021 May 7;5(3):zrab001. doi: 10.1093/bjsopen/zrab001. PMID 34137446
• Matsuda T, Kawai C, Sakurai T. [NMR blood flow measurement and NMR angiography]. Nihon Rinsho. 1987 Jan;45(1):60-6. No abstract available. Japanese. PMID 3820687
• Abe K, Kitago M, Shinoda M, Yagi H, Abe Y, Oshima G, Hori S, Yokose T, Endo Y, Kitagawa Y. High risk pathogens and risk factors for postoperative pancreatic fistula after pancreatectomy; a retrospective case-controlled study. Int J Surg. 2020 Oct;82:136-142. doi: 10.1016/j.ijsu.2020.08.035. Epub 2020 Aug 27. PMID 32861892
• Miao Y, Lu Z, Yeo CJ, Vollmer CM Jr, Fernandez-Del Castillo C, Ghaneh P, Halloran CM, Kleeff J, de Rooij T, Werner J, Falconi M, Friess H, Zeh HJ, Izbicki JR, He J, Laukkarinen J, Dejong CH, Lillemoe KD, Conlon K, Takaori K, Gianotti L, Besselink MG, Del Chiaro M, Montorsi M, Tanaka M, Bockhorn M, Adham M, Olah A, Salvia R, Shrikhande SV, Hackert T, Shimosegawa T, Zureikat AH, Ceyhan GO, Peng Y, W PMID 32249092
• Rozich NS, Morris KT, Garwe T, Sarwar Z, Landmann A, Siems CB, Jones A, Butler CS, McGaha PK, Axtman BC, Edil BH, Lees JS. Blame it on the injury: Trauma is a risk factor for pancreatic fistula following distal pancreatectomy compared with elective resection. J Trauma Acute Care Surg. 2019 Dec;87(6):1289-1300. doi: 10.1097/TA.0000000000002495. PMID 31765347
• Ratnayake CBB, Wells C, Hammond J, French JJ, Windsor JA, Pandanaboyana S. Network meta-analysis comparing techniques and outcomes of stump closure after distal pancreatectomy. Br J Surg. 2019 Nov;106(12):1580-1589. doi: 10.1002/bjs.11291. Epub 2019 Oct 18. PMID 31626341

Identifiers

NCT: NCT06814249 · PS-PF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗