Clinical trial NCT05905549: Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy
Official title: Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy: a Retrospective Propensity Score-matched Comparison
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Laparoscopic Pancreaticoduodenectomy
Keywords: laparoscopic pancreaticoduodenectomy
pancreatic transection level
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who had underwent laparoscopic pancreaticoduodenectomy

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: the incidence of clinically relevant pancreatic fistula
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: surgical performance of pancreaticojejunostomy
timeFrame: intraoperatively
measure: postoperative morbidity
timeFrame: 3 months postoperatively
measure: postoperative mortality
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Bing Peng
role: STUDY_CHAIR
References:
citation: 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.
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.
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.