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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800940
Other study ID # 201809040RIND
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2019
Est. completion date March 27, 2023

Study information

Verified date March 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.


Description:

The most common major complication after pancreatic resection is postoperative pancreatic fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and after postoperative day 3 with an amylase content > 3 times the upper limit of normal serum level. Gradual withdrawal of surgically placed drains in patients who are clinically stable and tolerate a diet is generally adopted to hasten closure of POPF. For high-output fistulas (> 150-200 mL of amylase-rich fluid per day), patients are initially managed with fasting and enteral or parenteral nutrition. If fistula output decreases substantially with these measures and the patient remains clinically well, drain withdrawal is initiated and oral intake is slowly restarted. If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula. When the output decrease to less than 10 mL per day, the drains are removed. However, the current standard practice of gradual drain withdrawal is time consuming. Although clinically stable can be discharged with the drain, the drainage tube often remains in place for a prolonged period, with patient discomfort and increased medical cost. In a pilot study by the investigators, 32.5% (37/114) of POPF patients required drainage for longer than 21 days. Besides, there is also considerable risk of recurrent fluid collection along the drain tube tract after drain removal. The investigators' experience has shown that trans-drain occlusion of the drain tract achieves fistula closure, enabling immediate removal of the drain. In a pilot study, 20 patients underwent trans-catheter occlusion for POPFs that persisted for more than 3 weeks after placement of drainage tubes. No subjective symptoms or abnormalities in blood tests were noted in 17 patients after the procedure. Three patients had abdominal pain without signs of infection, and the pain spontaneously subsided after conservative treatment. POPF healed immediately after occlusion in all of the 20 patients without recurrence during follow-up. This multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for POPF that persists for longer than 21 days.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 27, 2023
Est. primary completion date November 27, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Patients who undergo pancreatectomy (including pancreatoduodenectomy with or without pylorus preservation, distal pancreatectomy, and central pancreatectomy) and develop POPF that persists for 3 weeks after its occurrence. - With POPF that persists for 3 weeks after occurrence Exclusion Criteria: - Younger than 20 years of age - Active infection not adequately controlled [body temperature ?38.5? and/or eukocytosis (WBC count >15,000 /uL)/leukopenia (WBC count <4,000 /uL)], have residual intra-abdominal fluid collection (largest diameter > 4cm) despite tube drainage on CT scan (with or without contrast, performed when the patient meet inclusion criteria). - Current or history of severe heart, lung, kidney, or liver failure - Karnofsky Performance Score <60 - Pregnant or lactating - Have received somatostatin or its analogue in the index admission - Decline to participate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Fistulography and trans-drain occlusion
Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube. Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed.
Fistulography
Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

Balcom JH 4th, Rattner DW, Warshaw AL, Chang Y, Fernandez-del Castillo C. Ten-year experience with 733 pancreatic resections: changing indications, older patients, and decreasing length of hospitalization. Arch Surg. 2001 Apr;136(4):391-8. doi: 10.1001/archsurg.136.4.391. — View Citation

Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001. — View Citation

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28. — View Citation

Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7. — View Citation

El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5. — View Citation

McMillan MT, Soi S, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, House MG, Hughes SJ, Kent TS, Kunstman JW, Malleo G, Miller BC, Salem RR, Soares K, Valero V, Wolfgang CL, Vollmer CM Jr. Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation. Ann Surg. 2016 Aug;264(2):344-52. doi: 10.1097/SLA.0000000000001537. — View Citation

Roberts KJ, Sutcliffe RP, Marudanayagam R, Hodson J, Isaac J, Muiesan P, Navarro A, Patel K, Jah A, Napetti S, Adair A, Lazaridis S, Prachalias A, Shingler G, Al-Sarireh B, Storey R, Smith AM, Shah N, Fusai G, Ahmed J, Abu Hilal M, Mirza DF. Scoring System to Predict Pancreatic Fistula After Pancreaticoduodenectomy: A UK Multicenter Study. Ann Surg. 2015 Jun;261(6):1191-7. doi: 10.1097/SLA.0000000000000997. — View Citation

Schlitt HJ, Schmidt U, Simunec D, Jager M, Aselmann H, Neipp M, Piso P. Morbidity and mortality associated with pancreatogastrostomy and pancreatojejunostomy following partial pancreatoduodenectomy. Br J Surg. 2002 Oct;89(10):1245-51. doi: 10.1046/j.1365-2168.2002.02202.x. — View Citation

Tjaden C, Hinz U, Hassenpflug M, Fritz F, Fritz S, Grenacher L, Buchler MW, Hackert T. Fluid collection after distal pancreatectomy: a frequent finding. HPB (Oxford). 2016 Jan;18(1):35-40. doi: 10.1016/j.hpb.2015.10.006. Epub 2015 Nov 18. — View Citation

Veillette G, Dominguez I, Ferrone C, Thayer SP, McGrath D, Warshaw AL, Fernandez-del Castillo C. Implications and management of pancreatic fistulas following pancreaticoduodenectomy: the Massachusetts General Hospital experience. Arch Surg. 2008 May;143(5):476-81. doi: 10.1001/archsurg.143.5.476. — View Citation

Yeo CJ, Cameron JL, Sohn TA, Lillemoe KD, Pitt HA, Talamini MA, Hruban RH, Ord SE, Sauter PK, Coleman J, Zahurak ML, Grochow LB, Abrams RA. Six hundred fifty consecutive pancreaticoduodenectomies in the 1990s: pathology, complications, and outcomes. Ann Surg. 1997 Sep;226(3):248-57; discussion 257-60. doi: 10.1097/00000658-199709000-00004. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of Treatment-Emergent Adverse Events Fever/infection or pain that develops within 48 hours after the allocated treatment, or any adverse events judged to be related to the treatment From treatment to discharge from the index admission, an average of 2 weeks
Primary Days to fistula closure Days from the randomly allocated treatment to fistula closure The date of fistula closure is the date on which the drain is removed after an output of ? 10 mL during 48 hours, without recurrence of fistula within the next 3 months
Secondary 30-day fistula closure rate Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months From enrollment to 4 months after fistula occurrence
Secondary Rate of persistent or recurrent POPF after initial drain removal Proportion of patients with fluid collection on follow-up CT, which is to be performed at 3 months after removal of drain or when recurrence of fistula is suspected clinically. From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first
Secondary Length of hospital stay after the assigned treatment Days from the assigned treatment to discharge From treatment to discharge from the index admission, an average of 2 weeks
Secondary Hospital costs after the assigned treatment Costs from the assigned treatment to discharge From treatment to discharge from the index admission, an average of 2 weeks
Secondary Rate of fistula-related complications Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up. From occurrence of fistula to 3 months after drain removal
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