NCT03083938

Brief Summary

Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue. Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration 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

First Submitted

Initial submission to the registry

March 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

March 14, 2017

Last Update Submit

August 28, 2017

Conditions

Periampullary CarcinomaPancreatic Fistula

Keywords

PancreatoduodenectomyOmentumWrappingRoll-upWhipple

Outcome Measures

Primary Outcomes (1)

  • Complication rate after using omental roll-up technique

    Complication rate after using omental roll-up technique compare with non-omental roll-up

    Within 30 days after surgery

Secondary Outcomes (1)

  • Pancreatic fistula rate after using omental roll-up technique

    Within 30 days after surgery

Study Arms (2)

Omental Roll-up

EXPERIMENTAL
Procedure: Omental Roll-up

No Omental Roll-up

NO INTERVENTION

Interventions

Omental Roll-upPROCEDURE

Using omentum roll-up pancreato-jejunal anastomosis

Omental Roll-up

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum

You may not qualify if:

  • Unresectable pancreatoduodenectomy
  • Patients underwent omentectomy from prior surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paramin Muangkaew

Bangkok, 10400, Thailand

RECRUITING

Related Publications (4)

  • Sakamoto Y, Shimada K, Esaki M, Kajiwara T, Sano T, Kosuge T. Wrapping the stump of the gastroduodenal artery using the falciform ligament during pancreaticoduodenectomy. J Am Coll Surg. 2007 Feb;204(2):334-6. doi: 10.1016/j.jamcollsurg.2006.11.015. No abstract available.

    PMID: 17254940BACKGROUND

  • Iannitti DA, Coburn NG, Somberg J, Ryder BA, Monchik J, Cioffi WG. Use of the round ligament of the liver to decrease pancreatic fistulas: a novel technique. J Am Coll Surg. 2006 Dec;203(6):857-64. doi: 10.1016/j.jamcollsurg.2006.08.021. Epub 2006 Oct 25.

    PMID: 17116554BACKGROUND

  • Ramia JM, de la Plaza R, Adel F, Ramiro C, Arteaga V, Garcia-Parreno J. Wrapping in pancreatic surgery: a systematic review. ANZ J Surg. 2014 Dec;84(12):921-4. doi: 10.1111/ans.12491. Epub 2013 Dec 19.

    PMID: 25720806BACKGROUND

  • Choi SB, Lee JS, Kim WB, Song TJ, Suh SO, Choi SY. Efficacy of the omental roll-up technique in pancreaticojejunostomy as a strategy to prevent pancreatic fistula after pancreaticoduodenectomy. Arch Surg. 2012 Feb;147(2):145-50. doi: 10.1001/archsurg.2011.865.

    PMID: 22351908BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Paramin Muangkaew, Doctor

CONTACT

+66860244424u4102064@gmail.com

Pongsatorn Tangtawee, Doctor

CONTACT

+66931959099pongsatorn.md@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 20, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

August 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)