Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy

Laparoscopic Pancreaticoduodenectomy Clinical Trial

Official title:

Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy: a Retrospective Propensity Score-matched Comparison

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05905549
• Other study ID #: 2023-167-2
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: West China Hospital
• Contact: Yunqiang Cai
• Phone: +862862539242
• Email: yunqiangcaiwch[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The level of pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD) is not conclusive. Theoretically, the level of pancreatic transection can significantly affect the occurrence of postoperative pancreatic fistula (POPF) by influencing both the blood supply to the anastomosis and the location of the main pancreatic duct in the pancreatic transverse section. The investigators conduct a retropective propensity score-matched comparison to compare the impact of extended pancreatic transection and conventional pancreatic transection on POPF and the performance of the pancreaticojejunostomy during LPD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. consecutive patients underwent elective laparoscopic pancreaticoduodenectomy within October 2019 to April 2023

2. the perioperative and follow-up study data information can be collected completely

3. The level of pancreatic neck dissection can be determined by postoperative abdominal CT

4. patients without the history of neoadjuvant chemotherapy or radiotherapy

Exclusion Criteria:

1. conversion to laparotomy due to various reasons during operation;

2. combined with resection and reconstruction of the portal vein or the superior mesenteric vein

3. combined with other organ resection

4. the perioperative and follow-up study data information can not be collected completely, or the level of pancreatic neck dissection can not be determined by postoperative abdominal CT

5. patients with the history of neoadjuvant chemotherapy or radiotherapy

6. the main pancreatic duct did not be found during the operation, the duct-to-mucosa pancreaticojejunostomy could not be performed

Related Conditions & MeSH terms

• Laparoscopic Pancreaticoduodenectomy

Intervention

Procedure:
• extended pancreatic transection during laparoscopic pancreaticoduodenectomy
the pancreatic transection was performed at the pancreatic neck beyond the left side of the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinrui Zhu,MD

References & Publications (3)

Bardol T, Delicque J, Hermida M, Herrero A, Guiu B, Fabre JM, Souche R. Neck transection level and postoperative pancreatic fistula after pancreaticoduodenectomy: A retrospective cohort study of 195 patients. Int J Surg. 2020 Oct;82:43-50. doi: 10.1016/j.ijsu.2020.08.001. Epub 2020 Aug 22. — View Citation

Jwa EK, Hwang S. Extended pancreatic transection for secure pancreatic reconstruction during pancreaticoduodenectomy. Ann Hepatobiliary Pancreat Surg. 2017 Aug;21(3):138-145. doi: 10.14701/ahbps.2017.21.3.138. Epub 2017 Aug 31. — View Citation

Strasberg SM, Drebin JA, Mokadam NA, Green DW, Jones KL, Ehlers JP, Linehan D. Prospective trial of a blood supply-based technique of pancreaticojejunostomy: effect on anastomotic failure in the Whipple procedure. J Am Coll Surg. 2002 Jun;194(6):746-58; discussion 759-60. doi: 10.1016/s1072-7515(02)01202-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of clinically relevant pancreatic fistula	the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading	3 months postoperatively
Secondary	surgical performance of pancreaticojejunostomy	the duration of pancreaticojejunostomy	intraoperatively
Secondary	postoperative morbidity	postoperative morbidity (Clavien-Dindo score =3) within 3 months postoperatively	3 months postoperatively
Secondary	postoperative mortality	mortality within 3 months postoperatively	3 months postoperatively