NCT05475275

Brief Summary

The aim of this study was to reduce the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy by using different pancreaticojejunostomy methods according to the position of the pancreatic duct.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
924

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 11, 2022

Last Update Submit

July 24, 2022

Conditions

PancreaticoduodenectomyPostoperative Pancreatic Fistula

Keywords

pancreaticoduodenectomypancreaticojejunostomypostoperative pancreatic fistulapancreatic duct

Outcome Measures

Primary Outcomes (1)

  • Postoperative pancreatic fistula(POPF) as assessed by 2016 ISGPS definition

    2016 ISGPS definition(POPF):A drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.

    Within 30 days

Secondary Outcomes (2)

  • Postoperative hemorrhage as assessed by ISGPS definition

    Within 30 days

  • Delayed gastric emptying as assessed by ISGPS definition

    Within 30 days

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was \<0.401, it was divided into the N2 group (eccentric pancreatic duct). The "central pancreatic duct" group was given "1+1 mode" pancreaticojejunostomy; the "eccentric pancreatic duct" group was given "1+1² mode" pancreaticojejunostomy.

Procedure: pancreaticojejunostomy

Control group

ACTIVE COMPARATOR

The patients in the control group were given "traditional pancreaticojejunostomy"

Procedure: pancreaticojejunostomy

Interventions

pancreaticojejunostomyPROCEDURE

The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was \<0.401, it was divided into the N2 group (eccentric pancreatic duct). The "central pancreatic duct" group was given "1+1 mode" pancreaticojejunostomy; the "eccentric pancreatic duct" group was given "1+1² mode" pancreaticojejunostomy.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of benign or malignant peri-ampullary diseases
  • The participants have age more than18 years
  • The participants have adequate organ function to tolerate surgery

You may not qualify if:

  • \*The participants undergoing other organ surgery at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bole Tian

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (7)

  • Wu C, Hou SZ, Wu Z, Huang X, Wang Z, Tian B. Prognostic Nomogram for patients undergoing radical Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head. BMC Cancer. 2021 May 27;21(1):624. doi: 10.1186/s12885-021-08295-5.

    PMID: 34044806RESULT

  • Wang WG, Fu L, Babu SR, Wang L, Liang CP, Tian BL. Incidence of and Risk Factors and Reinterventions for Post-Pancreatoduodenectomy Hemorrhage: Retrospective Analysis. Dig Surg. 2018;35(1):19-27. doi: 10.1159/000460263. Epub 2017 Apr 7.

    PMID: 28384642RESULT

  • Su AP, Zhang Y, Ke NW, Lu HM, Tian BL, Hu WM, Zhang ZD. Triple-layer duct-to-mucosa pancreaticojejunostomy with resection of jejunal serosa decreased pancreatic fistula after pancreaticoduodenectomy. J Surg Res. 2014 Jan;186(1):184-91. doi: 10.1016/j.jss.2013.08.029. Epub 2013 Sep 21.

    PMID: 24095023RESULT

  • Su AP, Ke NW, Zhang Y, Wang WG, Zhang ZD, Liu XB, Hu WM, Tian BL. Does modified Braun enteroenterostomy improve alkaline reflux gastritis and marginal ulcer after pancreaticoduodenectomy? Dig Dis Sci. 2013 Nov;58(11):3224-31. doi: 10.1007/s10620-013-2803-x. Epub 2013 Aug 6.

    PMID: 23918152RESULT

  • Hirono S, Kawai M, Okada KI, Miyazawa M, Kitahata Y, Hayami S, Ueno M, Yamaue H. Modified Blumgart Mattress Suture Versus Conventional Interrupted Suture in Pancreaticojejunostomy During Pancreaticoduodenectomy: Randomized Controlled Trial. Ann Surg. 2019 Feb;269(2):243-251. doi: 10.1097/SLA.0000000000002802.

    PMID: 29697455RESULT

  • Ecker BL, McMillan MT, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Dickson EJ, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, Haverick E, Hollis RH, House MG, Hughes SJ, Jamieson NB, Javed AA, Kent TS, Kowalsky SJ, Kunstman JW, Malleo G, Poruk KE, Salem RR, Schmidt CR, Soares K, Stauffer JA, Valero V, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Characterization and Optimal Management of High-risk Pancreatic Anastomoses During Pancreatoduodenectomy. Ann Surg. 2018 Apr;267(4):608-616. doi: 10.1097/SLA.0000000000002327.

    PMID: 28594741RESULT

  • Keck T, Wellner UF, Bahra M, Klein F, Sick O, Niedergethmann M, Wilhelm TJ, Farkas SA, Borner T, Bruns C, Kleespies A, Kleeff J, Mihaljevic AL, Uhl W, Chromik A, Fendrich V, Heeger K, Padberg W, Hecker A, Neumann UP, Junge K, Kalff JC, Glowka TR, Werner J, Knebel P, Piso P, Mayr M, Izbicki J, Vashist Y, Bronsert P, Bruckner T, Limprecht R, Diener MK, Rossion I, Wegener I, Hopt UT. Pancreatogastrostomy Versus Pancreatojejunostomy for RECOnstruction After PANCreatoduodenectomy (RECOPANC, DRKS 00000767): Perioperative and Long-term Results of a Multicenter Randomized Controlled Trial. Ann Surg. 2016 Mar;263(3):440-9. doi: 10.1097/SLA.0000000000001240.

    PMID: 26135690RESULT

MeSH Terms

Interventions

Pancreaticojejunostomy

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Bole Tian, MD

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Bole Tian, MD

CONTACT

86-28-85422474hxtbl0338@163.com

Junjie Xiong, MD

CONTACT

86-28-85422474junjiex2011@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Enclosed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients were randomly divided into the experimental group and the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 26, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)