A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy

Pancreatic Fistula Clinical Trial

Official title:

A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201653
• Other study ID #: 201507019RIND
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2016
• Last updated: June 25, 2017
• Start date: July 2017
• Est. completion date: December 2019

Study information

• Verified date: June 2016
• Source: National Taiwan University Hospital
• Contact: Ting-Chun Kuo, MD
• Phone: +886-2-23123456
• Email: tina[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to 60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP (12% to 40%). POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem. However, all the previous reports were retrospective review, non-randomized study, or individual experience and showed no significant improvement of overall POPF. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.

Description:

Pancreatic surgery has been called formidable operation not only the technical challenge to surgeons but also demanding for patients. It evolved into a safe procedure with mortality rates of <5% recently, cutting down gradually from 25% in the 1960s. However, overall morbidity rate remained high ranging from 30% to 60%.

Distal pancreatectomy (DP) has been believed a safer and minor procedure compared with pancreatic head resection including standard pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), or duodenum-preserving pancreatic head resection (DPPHR). Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP. Büchler et al observed that the POPF rate was in fact significantly higher after DP when compared to pancreatic head resections. The variable documented incidence of POPF following DP ranges from 12% to 40%. POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem.

Although the majority of complications are not life-threatening, POPF could prolong hospitalization, expend expenditure for healthcare, abrade the quality of life; moreover, delay in further management for a fraction of patients with malignancy. Over the past two decades, various risk factors and multitudinous operative procedures have been held for reduction POPD following DP. These include underlying disease process, method of stump closure, and concomitant splenectomy However, all these reports were retrospective review, non-randomized study, or individual experience. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• age>= 20 years

• scheduled distal pancreatectomy at NTUH

• unable to realize this trial and willing to sign the informed consent form

Exclusion Criteria:

• age< 20 years, pregnent women, breast-feeding women, or mentally illed

• active malignancy within 2 years

• received other upper abdomen major surgery

• scheduled spleen preservation or associated major organ resection

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Procedure:
• Stump closure using NU-KNIT SURGICEL
We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POPF rate	The percentage of overall (grade A, B, C) POPF.	through study completion, an average of 16 days
Secondary	Duration of drainage replacement	Duration of drainage replacement after DP	through study completion, an average of 16 days
Secondary	Hospitalization	Duration of hospital stay after DP	through study completion, an average of 16 days
Secondary	Hospitalization cost	Total hospital cost of for DP	through study completion, an average of 16 days
Secondary	Mortality	Procedure-related mortality after DP	90 days